Study Stopped
A strategic decision was made to not further execute the study. This decision was not based on a safety concern.
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
PENGUIN-2
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection
3 other identifiers
interventional
1
6 countries
12
Brief Summary
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2021
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedStudy Start
First participant enrolled
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2021
CompletedResults Posted
Study results publicly available
March 6, 2024
CompletedMarch 6, 2024
January 1, 2024
2 months
August 12, 2021
February 8, 2024
February 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI])
Percentage of participants with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were planned to be reported.
Week 24
Secondary Outcomes (23)
Percentage of Participants With Adverse Events (AEs)
Up to 1 month 26 days
Percentage of Participants With Serious Adverse Events (SAEs)
Up to 1 month 26 days
Percentage of Participants With Abnormalities in Clinical Laboratory Tests
Up to 1 month 26 days
Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs)
Up to 1 month 26 days
Percentage of Participants With Abnormalities in Vital Signs
Up to 1 month 26 days
- +18 more secondary outcomes
Study Arms (3)
Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a)
EXPERIMENTALParticipants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks for 24 weeks plus NA treatment (either entecavir \[ETV\], tenofovir disoproxil or tenofovir alafenamide \[TAF\] tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly for 24 weeks.
Arm 2: JNJ-73763989 + NA + PegIFN-alpha-2a
EXPERIMENTALParticipants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil, or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from Week 12 till Week 24.
Arm 3: JNJ-73763989 + NA + PegIFN-alpha-2a
EXPERIMENTALParticipants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from baseline till Week 12.
Interventions
JNJ-73763989 will be administered subcutaneously once every 4 weeks.
PegIFN-alpha-2a will be administered subcutaneously once weekly.
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
TAF film-coated tablet will be administered orally once daily.
ETV film-coated tablet will be administered orally once daily.
Eligibility Criteria
You may qualify if:
- Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive
- Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (\<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values \< 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart
- Hepatitis B surface antigen (HBsAg) greater than (\>) 5 IU/mL at screening
- Fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) within 6 months prior to screening
You may not qualify if:
- History or signs of cirrhosis or portal hypertension
- Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection
- Liver disease of non-HBV etiology
- Clinically relevant alcohol or drug abuse within 12 months of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
I.D. Care, Inc.
Hillsborough, New Jersey, 08844, United States
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7, Canada
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5, Canada
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
Gdansk, 80405, Poland
ID Clinic
Mysłowice, 41-400, Poland
EMC Instytut Medyczny SA
Wroclaw, 50-220, Poland
Hosp. Univ. Vall D Hebron
Barcelona, 8035, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28032, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Alvaro Cunqueiro
Vigo, 36213, Spain
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only 1 participant was enrolled in the study in Arm 1. Participants were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study terminated prematurely based on a strategic decision and not for safety reasons.
Results Point of Contact
- Title
- Study Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2021
First Posted
August 13, 2021
Study Start
November 3, 2021
Primary Completion
December 29, 2021
Study Completion
December 29, 2021
Last Updated
March 6, 2024
Results First Posted
March 6, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
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