A Clinical Study to Evaluate the 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.

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. - The PENGUIN-2 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002450-81-ES

Enrollment

102

Registered

2021-08-05

Start date

2021-10-08

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Virus Infection MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: JNJ-73763989 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not yet assigned Current Sponsor code: JNJ-73763989 Other descriptive name: JNJ-73763989 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A01. Adult male or female participants =18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive. M02. Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead ECG performed at screening. A03. Participants must have chronic HBV infection. M04. Participants must have a body mass index between 18.0 and 35.0 kg/m2, extremes included. A05. Participants must sign a Master ICF and must sign the ICF specific for this intervention cohort, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Please refer to the study protocol for a full list of inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 97 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening. A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening. M03. History or evidence of clinical signs or symptoms of hepatic decompensation. M04. Participants with evidence of liver disease of non-HBV etiology. A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities. Please refer to the study protocol for a full list of exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy in terms of HBsAg changes from baseline for the treatment regimens.;Secondary Objective: 1. To evaluate the safety and tolerability of the study intervention. 2. To evaluate the efficacy of the study intervention during the follow-up period. 3. To evaluate the efficacy of the study intervention as measured by blood markers during the study intervention and follow-up (FU) period. 4. To evaluate the frequency of virologic breakthrough throughout the study. 5. To evaluate the PK of JNJ-3989, and optionally of NA and PegIFN-a2a.;Primary end point(s): Proportion of participants with an HBsAg level <100 IU/mL at Week 24.;Timepoint(s) of evaluation of this end point: Week 24.	—

Measure

Time frame

Main Objective: To evaluate the efficacy in terms of HBsAg changes from baseline for the treatment regimens.;Secondary Objective: 1. To evaluate the safety and tolerability of the study intervention. 2. To evaluate the efficacy of the study intervention during the follow-up period. 3. To evaluate the efficacy of the study intervention as measured by blood markers during the study intervention and follow-up (FU) period. 4. To evaluate the frequency of virologic breakthrough throughout the study. 5. To evaluate the PK of JNJ-3989, and optionally of NA and PegIFN-a2a.;Primary end point(s): Proportion of participants with an HBsAg level <100 IU/mL at Week 24.;Timepoint(s) of evaluation of this end point: Week 24.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Safety and tolerability including but not limited to the proportion of participants with (S)AEs and abnormalities in clinical laboratory tests, 12-lead ECGs, vital signs, and ophthalmic and physical examinations throughout the study. 2a. Proportion of participants with HBsAg seroclearance at FU Week 24 and 48 without re-starting NA treatment. 2b. Proportion of participants with HBV DNA <LLOQ at FU Week 24 and 48 without re-starting NA treatment. 2c. Frequency of virologic and/or biochemical flares. 2d. Proportion of participants requiring NA re treatment. 3a. Proportion of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time. 3b. Proportion of participants with HBsAg seroconversion. 3c. Change from baseline over time in HBsAg. 3d. Time to achieve HBsAg seroclearance/ seroconversion, and/or HBV DNA <LLOQ. 4. Proportion of participants with virologic breakthrough. 5a. PK parameters of JNJ-3989. 5b. Optionally, PK parameters of NA and/or PegIFN-a2a.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.	—

Measure

Time frame

Secondary end point(s): 1. Safety and tolerability including but not limited to the proportion of participants with (S)AEs and abnormalities in clinical laboratory tests, 12-lead ECGs, vital signs, and ophthalmic and physical examinations throughout the study. 2a. Proportion of participants with HBsAg seroclearance at FU Week 24 and 48 without re-starting NA treatment. 2b. Proportion of participants with HBV DNA <LLOQ at FU Week 24 and 48 without re-starting NA treatment. 2c. Frequency of virologic and/or biochemical flares. 2d. Proportion of participants requiring NA re treatment. 3a. Proportion of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time. 3b. Proportion of participants with HBsAg seroconversion. 3c. Change from baseline over time in HBsAg. 3d. Time to achieve HBsAg seroclearance/ seroconversion, and/or HBV DNA <LLOQ. 4. Proportion of participants with virologic breakthrough. 5a. PK parameters of JNJ-3989. 5b. Optionally, PK parameters of NA and/or PegIFN-a2a.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.

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Countries

Canada, Hong Kong, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactGlobal Development

JANSSEN CILAG, S.A.

ebellonm@its.jnj.com0034917228000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026