Trials / Completed
CompletedNCT04535544
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-73763989 | JNJ-73763989 will be administered as a SC injection. |
| DRUG | Placebo | Matching placebo to JNJ-73763989 will be administered as a SC injection. |
| DRUG | Entecavir (ETV) monohydrate | ETV monohydrate film coated tablet will be administered orally. |
| DRUG | Tenofovir disoproxil | Tenofovir disoproxil film-coated tablet will be administered orally. |
| DRUG | Tenofovir alafenamide (TAF) | TAF film coated tablet will be administered orally. |
Timeline
- Start date
- 2020-09-17
- Primary completion
- 2023-10-19
- Completion
- 2025-03-05
- First posted
- 2020-09-02
- Last updated
- 2025-04-25
- Results posted
- 2024-11-06
Locations
61 sites across 15 countries: United States, Australia, Brazil, China, France, Germany, Italy, Japan, New Zealand, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04535544. Inclusion in this directory is not an endorsement.