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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/NCT05763576
Registration number
NCT05763576
Ethics application status
Date submitted
28/02/2023
Date registered
10/03/2023
Date last updated
10/06/2024
Titles & IDs
Public title
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
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Scientific title
A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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EU Trial Number
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Secondary ID [2]
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BP44118
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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:
Chronic Hepatitis B
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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
Treatment: Drugs - RO7565020
Other interventions - Placebo
Treatment: Drugs - Nucleos(t)ide analogue (NUC) treatment
Experimental: RO7565020 -
Placebo Comparator: Placebo -
Treatment: Drugs: RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
Other interventions: Placebo
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Treatment: Drugs: Nucleos(t)ide analogue (NUC) treatment
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Percentage of Healthy Volunteers With Adverse Events
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Assessment method [1]
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Timepoint [1]
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Up to 104 weeks
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Primary outcome [2]
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Percentage of Participants With Chronic Hepatitis B With Adverse Events
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Assessment method [2]
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Timepoint [2]
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Up to 104 weeks
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Secondary outcome [1]
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Serum Concentrations of RO7565020
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Assessment method [1]
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Timepoint [1]
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Up to 104 weeks
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Secondary outcome [2]
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Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
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Assessment method [2]
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Timepoint [2]
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Up to 104 weeks
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Secondary outcome [3]
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Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints
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Assessment method [3]
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Timepoint [3]
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Up to 104 weeks
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Secondary outcome [4]
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Percentage of Participants With HBsAg Loss
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Assessment method [4]
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Timepoint [4]
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Up to 104 weeks
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Secondary outcome [5]
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Percentage of Participants With HBsAg Seroconversion
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Assessment method [5]
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Timepoint [5]
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Up to 104 weeks
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Secondary outcome [6]
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
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Assessment method [6]
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Timepoint [6]
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Up to 104 weeks
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Secondary outcome [7]
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Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
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Assessment method [7]
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Timepoint [7]
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Up to 104 weeks
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Eligibility
Key inclusion criteria
Healthy volunteers:
- Healthy participants
- Body mass index (BMI) between 18 and 32 kg/m^2
CHB participants:
- CHB infection (HBsAg-positive for >/= 6 months)
- On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months
- Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating
liver disease consistent with chronic HBV infection without evidence of bridging
fibrosis or cirrhosis
- BMI between 18 and 32 kg/m^2
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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
Healthy volunteers:
- History of any clinically significant disease
- Concomitant disease that could interfere with treatment or conduct of study
- Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing
(whichever is longer)
CHB participants:
- Evidence of liver cirrhosis or decompensated liver disease
- History or suspicion of hepatocellular carcinoma (HCC)
- History or evidence of a medical condition associated with chronic liver disease other
than HBV infection, or clinically significant and not adequately controlled
non-hepatic disease
- History of or currently receiving any systemic anti-neoplastic or immune-modulatory
treatment within the 8 weeks prior to the first dosing or the expectation that such
treatment will be needed at any time during the study.
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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
Other
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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
Recruiting
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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
28/04/2023
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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
1/02/2027
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Bulgaria
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State/province [2]
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Sofia
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Country [3]
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France
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State/province [3]
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Clichy cedex
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Country [4]
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France
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State/province [4]
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Paris
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Country [5]
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Hong Kong
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State/province [5]
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Hong Kong
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Country [6]
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Hong Kong
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State/province [6]
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Shatin, New Territories
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Country [7]
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Korea, Republic of
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State/province [7]
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Chuncheon
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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New Zealand
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State/province [9]
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Auckland
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Country [10]
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Spain
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State/province [10]
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Pontevedra
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Country [11]
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Taiwan
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State/province [11]
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Taoyuan City
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Country [12]
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Thailand
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State/province [12]
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Bangkok
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Country [13]
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Thailand
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State/province [13]
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Chiang Mai
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I
clinical study of RO7565020 to investigate the safety and tolerability and to characterize
the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020
in healthy participants and/or virologically suppressed participants with chronic hepatitis B
(CHB).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05763576
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: BP44118 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05763576
Download to PDF