At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ-56136379 in Patients With Chronic Hepatitis B Virus Infection
In Brief
A Phase 2 clinical trial evaluating JNJ-73763989, JNJ-56136379, and 4 other interventions for Hepatitis B. Completed, enrolled 24 participants across 10 sites in 9 countries.
Detailed Summary
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
Study Details
Timeline
Interventions
JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.
TAF will be administered orally once daily up to 48 weeks as NA treatment.
PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.