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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/NCT04667104
Registration number
NCT04667104
Ethics application status
Date submitted
9/12/2020
Date registered
14/12/2020
Date last updated
17/05/2023
Titles & IDs
Public title
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
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Scientific title
A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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2020-003956-34
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Secondary ID [2]
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CR108928
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Universal Trial Number (UTN)
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Trial acronym
PENGUIN
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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
Treatment: Drugs - JNJ-73763989
Treatment: Drugs - Tenofovir disoproxil
Treatment: Drugs - Tenofovir alafenamide (TAF)
Treatment: Drugs - Entecavir (ETV) monohydrate
Treatment: Drugs - PegIFN-alpha2a
Experimental: Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a) - Participants will receive combination treatment with JNJ-73763989+ nucleos(t)ide analog (NA) for 12 weeks during Treatment Period 1 and the participants who meet the eligibility criteria for PegIFN-alpha2a at Week 12 will receive combination treatment with JNJ-73763989 + NA plus PegIFN-a2a for 12 weeks during Treatment Period 2.
Treatment: Drugs: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Treatment: Drugs: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
Treatment: Drugs: Tenofovir alafenamide (TAF)
TAF film-coated tablet will be administered orally once daily.
Treatment: Drugs: Entecavir (ETV) monohydrate
ETV monohydrate film-coated tablet will be administered orally once daily.
Treatment: Drugs: PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.
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Intervention code [1]
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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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Percentage of Participants with a Reduction of at Least 2 log10 IU/mL in Hepatitis B Surface Antigen (HBsAg) Levels
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Assessment method [1]
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Percentage of participants with a reduction of at least 2 log10 international units per milliliter (IU/mL) in HBsAg levels from baseline to Week 24 will be reported.
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Timepoint [1]
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From Baseline up to Week 24 (end of study intervention)
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Secondary outcome [1]
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Percentage of Participants with Adverse Events (AEs) and Serious AEs
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [1]
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Up to Week 72
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Secondary outcome [2]
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Number of Participants with Abnormalities in Vital Signs and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability
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Assessment method [2]
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Number of participants with abnormalities in vital signs and clinically significant laboratory findings will be reported.
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Timepoint [2]
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Up to Week 72
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Secondary outcome [3]
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Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECGs)
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Assessment method [3]
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Percentage of participants with abnormalities (heart rate, PR, QRS and QT corrected [QTc]) in 12- lead ECGs will be reported.
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Timepoint [3]
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Up to Week 28
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Secondary outcome [4]
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Number of Participants with Abnormalities in Ophthalmic and Physical Examination as a Measure of Safety and Tolerability
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Assessment method [4]
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Number of participants with abnormalities in ophthalmic and physical examination will be reported.
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Timepoint [4]
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Up to Week 24
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Secondary outcome [5]
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Percentage of Participants Meeting the Protocol-defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
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Assessment method [5]
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Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI will be reported.
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Timepoint [5]
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Up to Week 72
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Secondary outcome [6]
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Percentage of Participants with Hepatitis B e Antigen (HBeAg), HBsAg, and Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) and ALT Levels
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Assessment method [6]
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Percentage of participants with HBeAg, HBsAg, and HBV DNA levels and alanine aminotransferase (ALT) levels below/above different cut-offs will be reported.
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Timepoint [6]
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Up to Week 72
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Secondary outcome [7]
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Percentage of Participants with HBsAg and HBeAg Seroconversion
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Assessment method [7]
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Percentage of participants with HBsAg and HBeAg seroconversion (Unit: International units per milliliter) will be reported.
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Timepoint [7]
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Up to Week 72
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Secondary outcome [8]
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Change from Baseline Over Time in HBsAg, HBeAg and HBV DNA Levels
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Assessment method [8]
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Change from baseline over time in HBsAg, HBeAg and HBV DNA levels (Unit: International units per milliliter) will be reported.
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Timepoint [8]
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Baseline, Up to Week 72
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Secondary outcome [9]
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Time to Achieve HBsAg, HBeAg and HBV DNA Levels Seroclearance/Seroconversion
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Assessment method [9]
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Time to achieve HBsAg, HBeAg and HBV DNA levels seroclearance/seroconversion (Unit: International units per milliliter) will be reported.
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Timepoint [9]
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Up to Week 72
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Secondary outcome [10]
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Percentage of Participants with Virologic Breakthrough
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Assessment method [10]
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Percentage of participants with virologic breakthrough will be reported.
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Timepoint [10]
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Up to Week 72
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Secondary outcome [11]
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Percentage of Participants with HBV DNA < LLOQ
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Assessment method [11]
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Percentage of participants with HBV DNA < LLOQ will be reported.
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Timepoint [11]
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At Week 48
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Secondary outcome [12]
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Percentage of Participants with Virologic and/or Biochemical Flares
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Assessment method [12]
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Percentage of participants with virologic and/or biochemical flares will be reported.
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Timepoint [12]
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Up to Week 72
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Secondary outcome [13]
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Percentage of Participants Requiring NA Re-treatment
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Assessment method [13]
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Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported.
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Timepoint [13]
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Up to Week 72
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Secondary outcome [14]
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Serum Concentration of of JNJ-3989
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Assessment method [14]
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Serum samples will be analyzed to determine concentrations of JNJ-3989.
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Timepoint [14]
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Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141)
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Secondary outcome [15]
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Serum Concentration of JNJ-6379 (Optional)
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Assessment method [15]
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Serum samples will be analyzed to determine concentrations of JNJ-6379.
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Timepoint [15]
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Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141)
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Secondary outcome [16]
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Serum Concentration of Nucleos(t)ide Analog (Optional)
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Assessment method [16]
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Serum samples will be analyzed to determine concentrations of nucleos(t)ide analog.
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Timepoint [16]
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Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141)
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Secondary outcome [17]
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Serum Concentration of PegIFN-alpha2a (Optional)
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Assessment method [17]
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Serum samples will be analyzed to determine concentrations of PegIFN-alpha2.
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Timepoint [17]
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Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141)
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Eligibility
Key inclusion criteria
- Chronic hepatitis B virus (HBV) infection, hepatitis B e Antigen (HBeAg) positive or
negative with suppressed viral replication under nucleos(t)ide analogue treatment for
at least 6 months prior to screening
- Medically stable based on physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at screening
- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2),
extremes included
- Must have serum HBsAg greater than (>) 100 international units per milliliter (IU/mL)
at screening, as assessed by quantitative HBsAg assay
- Must have a fibroscan stiffness measurement less than or equal to (<=) 9.0 Kilopascal
(kPa) at screening
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Minimum age
18
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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?
No
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Key exclusion criteria
- Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus
type 1 (HIV) or HIV-2 infection at screening
- History or evidence of clinical signs or symptoms of hepatic decompensation, including
but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal
varices
- Evidence of liver disease of non-HBV etiology
- Participants with a history of malignancy within 5 years before screening
- Contraindications to the use of pegylated interferon alpha-2a
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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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
1/02/2021
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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
17/04/2023
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Japan
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State/province [1]
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Bunkyo-Ku
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Country [2]
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Japan
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State/province [2]
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Suita-shi
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Papatoetoe
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Country [5]
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Poland
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State/province [5]
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Gdansk
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Country [6]
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Poland
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State/province [6]
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Myslowice
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Country [7]
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Poland
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State/province [7]
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Warszawa
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Country [8]
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Poland
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State/province [8]
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Wroclaw
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Country [9]
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Taiwan
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State/province [9]
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Kaohsiung
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Country [10]
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Taiwan
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State/province [10]
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Taichung
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Country [11]
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Taiwan
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State/province [11]
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Tainan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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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
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen
(HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 +
nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a]).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04667104
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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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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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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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Address
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04667104
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