drugset / Trial / NCT04535544
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2020-09-17
- Primary completion
- 2023-10-19
- Completion
- 2025-03-05
Outcome
Met primary endpoint
registry Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA) vs Part 1: Placebo + NA; p = 0.011; Difference of percentage 23.7 (95% CI 3.52 to 43.96) NCT04535544 ↗
registry Part 2: JNJ-73763989 + NA vs Part 2: Placebo + NA; p = 0.003; Difference of percentage 26.8 (95% CI 7.38 to 46.21) NCT04535544 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-73763989 | Small interfering RNA (siRNA) | — | Subcutaneous |
| Background | Entecavir | Small molecule | — | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Background | tenofovir alafenamide | Small molecule | — | Oral |