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NCT04171765 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
A Phase 2 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT04171765: Clinical Trial Phase 2 study, sponsored by Genentech.
NCT04171765 is a Phase 2 study that was terminated before completion, run by Genentech. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04171765, a Phase 2 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
Primary Outcome
Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.
Interventions
- DRUG Placebo
- DRUG BFKB8488A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2023-01-23 |
| Phase | Phase 2 |
Why NCT04171765 stopped before completion
NCT04171765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04171765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04171765 about?
NCT04171765 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis". This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
What is the current status of trial NCT04171765?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2020-09-30. Estimated completion is 2023-01-23.
What interventions are being tested in trial NCT04171765?
The interventions under investigation include: Placebo (DRUG), BFKB8488A (DRUG).
Who is sponsoring clinical trial NCT04171765?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04171765's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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