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NCT03633227 · ClinicalTrials.gov registry record · Phase 4
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
A Phase 4 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT03633227 is a Phase 4 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 22 participants.
The verdict
NCT03633227, a Phase 4 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-06-22 |
| Est. Completion | 2021-07-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03633227
The ClinicalTrials.gov registry entry for NCT03633227 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03633227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03633227 about?
NCT03633227 is a clinical study titled "Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment". This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatmen...
What is the current status of trial NCT03633227?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2018-06-22. Estimated completion is 2021-07-09.
What interventions are being tested in trial NCT03633227?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT03633227?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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