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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 193 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04620733
The ClinicalTrials.gov registry entry for NCT04620733 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04620733 reports 0 study locations.
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.
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