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

NCT04667104 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1089282020-003956-3473763989PAHPB2006
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 11

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 \[PegIFN-alpha2a\]).

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24

  Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24.

  From Baseline (Day 1) to Week 24

Secondary Outcomes (30)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

  Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

• Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

  Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

• Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability

  Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

• Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability

  Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

• Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability

  Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28

Study Arms (1)

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

EXPERIMENTAL

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; Drug: Tenofovir disoproxil; Drug: Tenofovir alafenamide (TAF); Drug: Entecavir (ETV) monohydrate; Drug: PegIFN-alpha2a

Interventions

JNJ-73763989 DRUG

JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.

Also known as: JNJ-3989

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

Tenofovir disoproxil DRUG

Tenofovir disoproxil film-coated tablet will be administered orally once daily.

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

Tenofovir alafenamide (TAF) DRUG

TAF film-coated tablet will be administered orally once daily.

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

Entecavir (ETV) monohydrate DRUG

ETV monohydrate film-coated tablet will be administered orally once daily.

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

PegIFN-alpha2a DRUG

PegIFN-alpha2a injection will be administered subcutaneously once weekly.

Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Tokyo Medical and Dental University Hospital

Bunkyō City, 113 8519, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

New Zealand Clinical Research

Auckland, 1010, New Zealand

Location

Middlemore Clinical Trials

Papatoetoe, 2025, New Zealand

Location

Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

Gdansk, 80-462, Poland

Location

ID Clinic

Mysłowice, 41-400, Poland

Location

Wojewodzki Szpital Zakazny w Warszawie

Warsaw, 01-201, Poland

Location

Przychodnia EuroMediCare Wroclaw Lowiecka

Wroclaw, 50 220, Poland

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• Gane E, Janczewska E, Takehara T, Chuang WL, Peng CY, Hlebowicz M, Asahina Y, Chang TT, Kalmeijer R, Jezorwski J, Kim G, Anastasiou Z, Kakuda TN, Verbinnen T, Pehlivanov N, Bakala A, Lenz O, Biermer M. Peginterferon-alpha-2a add-on to treatment with siRNA JNJ-73763989 in virologically suppressed chronic hepatitis B: The phase II PENGUIN study. JHEP Rep. 2025 Jul 9;7(10):101516. doi: 10.1016/j.jhepr.2025.101516. eCollection 2025 Oct.

  PMID: 40919077 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir; tenofovir alafenamide; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Registry Group
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 14, 2020
• Study Start: February 1, 2021
• Primary Completion: May 16, 2022
• Study Completion: April 17, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (2); TW (3); PL (4); NZ (2)