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NCT04620733 · ClinicalTrials.gov registry record · Phase 3
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
NCT04620733: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT04620733 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 193 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04620733, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
Study Summary
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.
Primary Outcome
Percentages were rounded-off.
Interventions
- DRUG Placebo
- DRUG Seladelpar 10 mg
- DRUG Seladelpar 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2023-08-11 |
| Phase | Phase 3 |
What the finished NCT04620733 record still lists
NCT04620733 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04620733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04620733 about?
NCT04620733 is a clinical study titled "RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)". The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of t...
What is the current status of trial NCT04620733?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2021-04-21. Estimated completion is 2023-08-11.
What interventions are being tested in trial NCT04620733?
The interventions under investigation include: Placebo (DRUG), Seladelpar 10 mg (DRUG), Seladelpar 5 mg (DRUG).
Who is sponsoring clinical trial NCT04620733?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04620733's enrollment target sits among peer trials
193 1397th of 2000 higher than 603 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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