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NCT04535544 · ClinicalTrials.gov registry record · Phase 2
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04535544: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04535544 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535544, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was
Interventions
- DRUG Placebo
- DRUG Tenofovir alafenamide (TAF)
- DRUG Tenofovir disoproxil
- DRUG JNJ-73763989
- DRUG Entecavir (ETV) monohydrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2025-03-05 |
| Phase | Phase 2 |
What the finished NCT04535544 record still lists
NCT04535544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04535544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04535544 about?
NCT04535544 is a clinical study titled "A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus". 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.
What is the current status of trial NCT04535544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2020-09-17. Estimated completion is 2025-03-05.
What interventions are being tested in trial NCT04535544?
The interventions under investigation include: Placebo (DRUG), Tenofovir alafenamide (TAF) (DRUG), Tenofovir disoproxil (DRUG), JNJ-73763989 (DRUG), Entecavir (ETV) monohydrate (DRUG).
Who is sponsoring clinical trial NCT04535544?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04535544's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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