A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Phase 2
Completed
NCT04535544
| Condition | Hepatitis D, Chronic |
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| Phase | Phase 2 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Completed |
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| Enrollment | 52 participants |
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| Interventions | JNJ-73763989, Entecavir (ETV) monohydrate, Tenofovir disoproxil, Tenofovir alafenamide (TAF) |
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| Start date | Sep 17, 2020 |
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| Completion date | Oct 19, 2023 |
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| Results posted | Nov 6, 2024 |
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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.
Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Week 48 · Percentage of Participants
| Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA) | 33.3 Percentage of Participants |
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| Part 1: Placebo + NA | 0.0 Percentage of Participants |
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Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach)
Week 48 · Percentage of Participants
| Part 2: JNJ-73763989 (JNJ-3989) + NA | 30.0 Percentage of Participants |
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| Part 2: Placebo + NA | 0.0 Percentage of Participants |
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Open in BENITIONS
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