A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
2期
已完成
NCT04535544
| 适应症 | Hepatitis D, Chronic |
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| 分期 | 2期 |
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| 申办方 | Janssen Research & Development, LLC |
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| 状态 | 已完成 |
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| 受试者人数 | 52 人 |
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| 干预（药物） | JNJ-73763989, Entecavir (ETV) monohydrate, Tenofovir disoproxil, Tenofovir alafenamide (TAF) |
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| 开始日期 | 2020年9月17日 |
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| 完成日期 | 2023年10月19日 |
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| 结果公布日 | 2024年11月6日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。