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 (PENGUIN)

May 15, 2023 updated by: Janssen Research & Development, LLC

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

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]).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but has been removed as part of amendment 3 of the study.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Bunkyo-Ku, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
  • New Zealand
      • Auckland, New Zealand, 1010
        • New Zealand Clinical Research
      • Papatoetoe, New Zealand, 2025
        • Middlemore Clinical Trials
  • Poland
      • Gdansk, Poland, 80-462
        • Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
      • Myslowice, Poland, 41-400
        • ID Clinic
      • Warszawa, Poland, 01-201
        • Wojewodzki Szpital Zakazny w Warszawie
      • Wroclaw, Poland, 50-220
        • Przychodnia EuroMediCare, Wroclaw Lowiecka
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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-α2a for 12 weeks during Treatment Period 2.
Drug: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Other Names:
  • JNJ-3989
Drug: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
Drug: Tenofovir alafenamide (TAF)
TAF film-coated tablet will be administered orally once daily.
Drug: Entecavir (ETV) monohydrate
ETV monohydrate film-coated tablet will be administered orally once daily.
Drug: PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with a Reduction of at Least 2 log10 IU/mL in Hepatitis B Surface Antigen (HBsAg) Levels
Time Frame: From Baseline up to Week 24 (end of study intervention)
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.
From Baseline up to Week 24 (end of study intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AEs) and Serious AEs
Time Frame: Up to Week 72
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.
Up to Week 72
Number of Participants with Abnormalities in Vital Signs and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability
Time Frame: Up to Week 72
Number of participants with abnormalities in vital signs and clinically significant laboratory findings will be reported.
Up to Week 72
Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECGs)
Time Frame: Up to Week 28
Percentage of participants with abnormalities (heart rate, PR, QRS and QT corrected [QTc]) in 12- lead ECGs will be reported.
Up to Week 28
Number of Participants with Abnormalities in Ophthalmic and Physical Examination as a Measure of Safety and Tolerability
Time Frame: Up to Week 24
Number of participants with abnormalities in ophthalmic and physical examination will be reported.
Up to Week 24
Percentage of Participants Meeting the Protocol-defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
Time Frame: Up to Week 72
Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI will be reported.
Up to Week 72
Percentage of Participants with Hepatitis B e Antigen (HBeAg), HBsAg, and Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) and ALT Levels
Time Frame: Up to Week 72
Percentage of participants with HBeAg, HBsAg, and HBV DNA levels and alanine aminotransferase (ALT) levels below/above different cut-offs will be reported.
Up to Week 72
Percentage of Participants with HBsAg and HBeAg Seroconversion
Time Frame: Up to Week 72
Percentage of participants with HBsAg and HBeAg seroconversion (Unit: International units per milliliter) will be reported.
Up to Week 72
Change from Baseline Over Time in HBsAg, HBeAg and HBV DNA Levels
Time Frame: Baseline, Up to Week 72
Change from baseline over time in HBsAg, HBeAg and HBV DNA levels (Unit: International units per milliliter) will be reported.
Baseline, Up to Week 72
Time to Achieve HBsAg, HBeAg and HBV DNA Levels Seroclearance/Seroconversion
Time Frame: Up to Week 72
Time to achieve HBsAg, HBeAg and HBV DNA levels seroclearance/seroconversion (Unit: International units per milliliter) will be reported.
Up to Week 72
Percentage of Participants with Virologic Breakthrough
Time Frame: Up to Week 72
Percentage of participants with virologic breakthrough will be reported.
Up to Week 72
Percentage of Participants with HBV DNA < LLOQ
Time Frame: At Week 48
Percentage of participants with HBV DNA < LLOQ will be reported.
At Week 48
Percentage of Participants with Virologic and/or Biochemical Flares
Time Frame: Up to Week 72
Percentage of participants with virologic and/or biochemical flares will be reported.
Up to Week 72
Percentage of Participants Requiring NA Re-treatment
Time Frame: Up to Week 72
Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported.
Up to Week 72
Serum Concentration of of JNJ-3989
Time Frame: 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)
Serum samples will be analyzed to determine concentrations of JNJ-3989.
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)
Serum Concentration of JNJ-6379 (Optional)
Time Frame: 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)
Serum samples will be analyzed to determine concentrations of JNJ-6379.
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)
Serum Concentration of Nucleos(t)ide Analog (Optional)
Time Frame: 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)
Serum samples will be analyzed to determine concentrations of nucleos(t)ide analog.
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)
Serum Concentration of PegIFN-alpha2a (Optional)
Time Frame: 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)
Serum samples will be analyzed to determine concentrations of PegIFN-alpha2.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108928
  • 2020-003956-34 (EudraCT Number)
  • 73763989PAHPB2006 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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