CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
JNJ-73763989 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04667104
NCT04667104Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Dec 14, 2020·Updated Jul 3, 2024

In Brief

A Phase 2 clinical trial evaluating JNJ-73763989, Tenofovir disoproxil, and 3 other interventions for Hepatitis B, Chronic. Completed, enrolled 48 participants across 11 sites in 4 countries.

Detailed 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 \[PegIFN-alpha2a\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesJapan, New Zealand, Poland, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartFeb 1, 2021
Primary CompletionMay 16, 2022
Study CompletionApr 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.5 years ago

Interventions

JNJ-73763989drug

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

Tenofovir disoproxildrug

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

Tenofovir alafenamide (TAF)drug

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

Entecavir (ETV) monohydratedrug

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

PegIFN-alpha2adrug

PegIFN-alpha2a injection will be administered subcutaneously once weekly.