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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02956850
Registration number
NCT02956850
Ethics application status
Date submitted
3/11/2016
Date registered
6/11/2016
Date last updated
8/02/2024
Titles & IDs
Public title
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
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Scientific title
A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-week Treatment of Patients With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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2016-003723-38
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Secondary ID [2]
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NP39305
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - RO7020531
Experimental: Part I: SAD in Healthy Volunteers - Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort. A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg.
Experimental: Part I: MAD in Healthy Volunteers - Healthy volunteers will receive RO7020531 (100 mg, 140 mg, and 170 mg as selected based on safety, pharmacokinetic (PK) and pharmacodynamic (PD) data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13.
Experimental: Part II: CHB Participants - CHB participants will receive RO7020531 (150 mg and 170 mg as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41, unless in Cohort 4 in case of once a week (QW) dosing as dose modification.
Other interventions: Placebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
Treatment: Drugs: RO7020531
RO7020531 will be administered as per schedule specified in the respective arm.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percentage of SAD Participants With Adverse Events (AEs)
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Assessment method [1]
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An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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Timepoint [1]
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From randomization up to Day 29
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Primary outcome [2]
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Part 1: Percentage of MAD Participants With AEs
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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Timepoint [2]
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From randomization up to Day 41
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Primary outcome [3]
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Part 2: Percentage of Chronic Hepatitis B Participants With AEs
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Assessment method [3]
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An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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Timepoint [3]
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From randomization up to Week 12
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Primary outcome [4]
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Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
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Assessment method [4]
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For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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Timepoint [4]
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From randomization up to Day 8
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Primary outcome [5]
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Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
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Assessment method [5]
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For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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Timepoint [5]
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From randomization up to Day 20
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Primary outcome [6]
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Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
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Assessment method [6]
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For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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Timepoint [6]
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From randomization up to Week 12
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Primary outcome [7]
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Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
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Assessment method [7]
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Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline.
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Timepoint [7]
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From randomization up to Day 8
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Primary outcome [8]
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Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters
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Assessment method [8]
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Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
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Timepoint [8]
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From randomization up to Day 20
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Primary outcome [9]
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Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
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Assessment method [9]
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Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
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Timepoint [9]
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From randomization up to Week 12
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Primary outcome [10]
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Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
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Assessment method [10]
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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Timepoint [10]
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From randomization up to Day 8
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Primary outcome [11]
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Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
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Assessment method [11]
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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Timepoint [11]
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From randomization up to Day 20
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Primary outcome [12]
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Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
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Assessment method [12]
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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Timepoint [12]
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From randomization up to Week 12
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Secondary outcome [1]
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Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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Assessment method [1]
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Timepoint [1]
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Secondary outcome [2]
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Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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Assessment method [2]
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Timepoint [2]
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Secondary outcome [3]
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Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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Assessment method [3]
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Timepoint [3]
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Secondary outcome [4]
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Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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Assessment method [4]
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Timepoint [4]
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Secondary outcome [5]
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Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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Assessment method [5]
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Timepoint [5]
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Secondary outcome [6]
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Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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Assessment method [6]
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0
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Timepoint [6]
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Secondary outcome [7]
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Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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Assessment method [7]
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Timepoint [7]
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Secondary outcome [8]
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Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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Assessment method [8]
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Timepoint [8]
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Secondary outcome [9]
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Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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Assessment method [9]
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Timepoint [9]
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Secondary outcome [10]
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Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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Assessment method [10]
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Timepoint [10]
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Secondary outcome [11]
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Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
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Assessment method [11]
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Total amount of the study drug and metabolites recovered in urine was reported.
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Timepoint [11]
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0
0 to 24 hrs Postdose on Day 1
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Secondary outcome [12]
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Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD
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Assessment method [12]
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Mean concentrations of IFN-alpha for SAD were calculated following single-dose and for MAD it was calculated following multiple doses. The standard deviation (SD) presented is actually the log transformed geometric standard deviation.
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Timepoint [12]
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SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Secondary outcome [13]
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Part 2: Mean Concentration of IFN-alpha
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Assessment method [13]
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Mean concentrations of IFN-alpha for Part 2 were calculated following multiple doses. The SD presented is actually the log transformed geometric standard deviation.
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Timepoint [13]
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Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Secondary outcome [14]
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Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
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Assessment method [14]
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Cytokines markers include Chemokine (C-X-C Motif) Ligand 10 (IP-10), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 p40 (IL-12 p40), Neopterin, Tumor Necrosis Factor-Alpha (TNF-alpha). The SD presented is actually the log transformed geometric standard deviation.
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Timepoint [14]
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SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Secondary outcome [15]
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Part 2: Mean Fold Change From Baseline in Cytokine Markers
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Assessment method [15]
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Cytokines markers included IP- 10, IL- 6, IL-1 10, IL-12 p40, Neopterin and TNF -alpha. The SD presented is actually the log transformed geometric standard deviation.
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Timepoint [15]
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Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Secondary outcome [16]
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Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
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Assessment method [16]
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Markers of transcriptional responses includes messenger ribonucleic acid interferon-stimulated gene 15(mRNA ISG15), messenger RNA oligoadenylate synthetase 1 (mRNA OAS1), messenger RNA myxovirus resistance 1 gene (mRNA MX-1), messenger RNA Toll-like receptor (mRNA TLR7). The SD presented is actually the log transformed geometric standard deviation.
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Timepoint [16]
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SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Secondary outcome [17]
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Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
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Assessment method [17]
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Transcriptional markers include mRNA ISG15, mRNA OAS1, mRNA MX-1, mRNA TLR7. The SD presented is actually the log transformed geometric standard deviation.
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Timepoint [17]
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Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41
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Secondary outcome [18]
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0
Effect of RO7020531 Dosing on ECG Parameters (PR [PQ], QRS, QT, QTcF in Miliseconds [ms]) Using Exposure-response Analysis: SAD and MAD
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Assessment method [18]
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0
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Timepoint [18]
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0
SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11
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Secondary outcome [19]
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Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
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Assessment method [19]
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Adefovir was not administered to any participants in the study. Hence, no data could be collected for plasma concentration of adefovir. As participants in each cohort received different NUCs the data for Cohorts 1, 2 and 3 have been reported separately.
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Timepoint [19]
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Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
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Eligibility
Key inclusion criteria
Part 1: SAD and MAD in Healthy Volunteers
- Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing
product) per day
- Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than
1:40 and with no associated history or symptoms of potential connective tissue disease
or other immune-mediated diseases
Part 2: CHB Participants
- CHB infection (positive test for Hepatitis B surface antigen [HBsAg] for more than 6
months prior to randomization)
- For Cohort 1, 2, 3 and 4: HBsAg detectable at screening
- For Cohort 1, 2 and 3: Hepatitis B virus deoxyribose nuclic acid (HBV DNA) < 90
international unit per milliliter (IU/mL) for at least 6 months prior to
randomization; HBV DNA < 90 IU/mL at screening by Roche Cobas assay
- For Cohort 4: HBV DNA at screening >= 2 × 10*4 IU/mL for HBeAg positive and >= 2 x
10*3 IU/mL for hepatitis B e antigen (HBeAg) negative participants
- For Cohort 1, 2 and 3: Alanine amino transferase (ALT) =<1.5 × upper limit of normal
(ULN) during the 6 months prior to randomization confirmed by two measurements
separated by at least 14 days; ALT at screening =< 1.5 × ULN.
- For Cohort 4: ALT and aspartate aminotransferase (AST) at screening and Day -1 visit:
=< 5 × ULN.
- Negative ANA test; or positive with dilutions not greater than 1:40 and with no
associated history or symptoms of potential connective tissue disease or other
immune-mediated diseases
- Liver biopsy, Fibroscan® or equivalent elastography test obtained within 6 months
prior to randomization demonstrating liver disease consistent with chronic HBV
infection with absence of cirrhosis and absence of extensive bridging fibrosis
(cirrhosis or extensive bridging fibrosis are defined as greater than or equal to
(>/=) Metavir 3, recommended cut-off for Fibroscan 8.5 kilopascals [kPa])
- For Cohort 1, 2 and 3: On treatment with tenofovir, entecavir, adefovir, or
telbivudine, either as single agents or in combination, for at least 6 months
- For Cohort 4: Hepatitis B virus (HBV) treatment naïve or not on any anti-HBV treatment
for the past 6 months
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Part 1: SAD and MAD in Healthy Volunteers
- History of immunologically mediated disease (e.g., inflammatory bowel disease,
idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic
anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or
any other autoimmune disease); clinically significant psychiatric disease, acute
infection (e.g., influenza), gastrointestinal (GI) disease (including inflammatory
bowel disease, peptic ulcer disease, GI hemorrhage)
- History of having received or currently receiving any systemic anti-neoplastic
(including radiation) or immune-modulatory treatment (including systemic oral or
inhaled corticosteroids, IFN or pegylated interferon [PEG-IFN]) within the 8 weeks
prior to the first dose of study drug or the expectation that such treatment will be
needed at any time during the study
- Any clinically significant concomitant disease or condition that could interfere with,
or for which the treatment of might interfere with, the conduct of the study, or that
would, in the opinion of the Investigator, pose an unacceptable risk to the
participant in this study
- Positive Hepatitis A virus antibody (HAV Ab IgM), HBsAg, Hepatitis C antibody (HCV
Ab), or positive for human immunodeficiency virus (HIV) at screening
- History of clinically significant thyroid disease; also, participants with clinically
significant elevated thyroid-stimulating hormone (TSH) concentrations at screening
- Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody
(ASMA) or thyroid peroxidase antibody
Part 2: CHB Participants
- History of liver cirrhosis
- History or other evidence of bleeding from esophageal varices
- Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or
clinical evidence such as ascites or varices)
- History or other evidence of a medical condition associated with chronic liver disease
other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver
disease, toxin exposure, thalassemia, nonalcoholic steato-hepatitis, etc.). A clinical
diagnosis of fatty liver is allowed provided that non alcoholic steatohepatitis (NASH)
has been excluded by liver biopsy.
- Documented history or other evidence of metabolic liver disease within one year of
randomization
- Positive test for Hepatitis A virus (IgM anti-HAV), Hepatitis C virus (HCV), Hepatitis
D virus, Hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- History of or suspicion of hepatocellular carcinoma or alpha fetoprotein >/=13
nanograms per milliliter (ng/mL) at screening
- History of immunologically mediated disease (e.g., inflammatory bowel disease,
idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic
anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or
any other autoimmune disease); clinically significant psychiatric disease; acute
infection (e.g., influenza); GI disease (including inflammatory bowel disease, peptic
ulcer disease, GI hemorrhage, or history of pancreatitis); clinically significant
cardiovascular (including postural hypotension), endocrine, renal, ocular, pulmonary
or neurological disease.
- History of having received or currently receiving any systemic anti-neoplastic
(including radiation) or immune-modulatory treatment (including systemic oral or
inhaled corticosteroids,IFN or PEG-IFN) within the 8 weeks prior to the first dose of
study drug or the expectation that such treatment will be needed at any time during
the study
- Cohort 4: Concurrent HBV treatments
- History of organ transplantation
- Clinically significant thyroid disease; also, participants with clinically significant
elevated TSH concentrations at screening
- Positive results for AMA, ASMA or thyroid peroxidase antibody
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/06/2021
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
Bulgaria
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State/province [1]
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0
Sofia
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Country [2]
0
0
Hong Kong
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State/province [2]
0
0
Hong Kong
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Country [3]
0
0
Hong Kong
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State/province [3]
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0
Shatin
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Country [4]
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0
Italy
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State/province [4]
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0
Emilia-Romagna
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Country [5]
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0
Italy
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State/province [5]
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0
Lombardia
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Country [6]
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0
Netherlands
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State/province [6]
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0
Amsterdam
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Country [7]
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0
New Zealand
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State/province [7]
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Auckland
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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Taiwan
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Xitun Dist.
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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United Kingdom
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Liverpool
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
Brief summary
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the
safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy
participants and in participants with chronic hepatitis B. Part I will be conducted in two
portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include
only healthy volunteers. Part II will commence after completion of the MAD portion of Part I
and will include only Chronic Hepatitis B (CHB) participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02956850
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02956850
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