Trials / Completed
CompletedNCT04585789
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The title of protocol reflects the original study design. The study design section is reflecting that the design as of protocol amendment 5 is non-randomized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-73763989 | JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44. |
| DRUG | JNJ-56136379 | JNJ-56136379 tablets will be administered orally once daily up to 48 weeks. |
| DRUG | Entecavir (ETV) | ETV tablet will be administered orally once daily up to 48 weeks as NA treatment. |
| DRUG | Tenofovir disoproxil | Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment. |
| DRUG | Tenofovir alafenamide (TAF) | TAF will be administered orally once daily up to 48 weeks as NA treatment. |
| DRUG | PegIFN-alpha-2a (Optional) | PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks. |
Timeline
- Start date
- 2021-03-11
- Primary completion
- 2023-02-08
- Completion
- 2024-01-09
- First posted
- 2020-10-14
- Last updated
- 2025-05-21
- Results posted
- 2024-03-05
Locations
10 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, New Zealand, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04585789. Inclusion in this directory is not an endorsement.