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NCT03112681 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
A Phase 2 study of Primary Biliary Cirrhosis, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 9
- Study locations
NCT03112681: Completed Phase 2 study of Primary Biliary Cirrhosis, sponsored by Zydus Therapeutics.
NCT03112681 is a Phase 2 study of Primary Biliary Cirrhosis that has completed, run by Zydus Therapeutics. The registered enrollment target is 37 participants, below the 1,437-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03112681, a Phase 2 study of Primary Biliary Cirrhosis, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 9
- Study locations
Study Summary
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC). A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.
Primary Outcome
Change in ALP levels after 16 weeks of Saroglitazar magnesium 2 mg and 4 mg treatment.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Saroglitazar magnesium 2 mg
- DRUG Saroglitazar magnesium 4 mg
Study Locations (9)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Einstein Medical Center Philadelphia - Philadelphia
California
- California Liver Research Institute - Pasadena
Florida
- Schiff Center for Liver Diseases/University of Miami - Miami
Georgia
- Gastrointestional Specialists of Georgia - Marietta
Indiana
- Indiana University School of Medicine - Indianapolis
New Jersey
- Rutgers NJ Medical School - Newark
North Carolina
- Carolinas Healthcare System - Charlotte
Ohio
- Consultants for Clinical Research - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-08-18 |
| Est. Completion | 2020-08-07 |
| Phase | Phase 2 |
What the finished NCT03112681 record still lists
NCT03112681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,437-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo Oral Tablet is the first listed.
NCT03112681 lists 9 locations in 8 states (Pennsylvania, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03112681 about?
NCT03112681 is a clinical study titled "Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis". prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC). A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar ...
What is the current status of trial NCT03112681?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2017-08-18. Estimated completion is 2020-08-07.
What conditions does trial NCT03112681 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis.
What interventions are being tested in trial NCT03112681?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Saroglitazar magnesium 2 mg (DRUG), Saroglitazar magnesium 4 mg (DRUG).
Who is sponsoring clinical trial NCT03112681?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03112681 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Indiana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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