Trials / Recruiting
RecruitingNCT06427395
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Zydus Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Detailed description
A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Saroglitazar Magnesium 1 mg | Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program |
Timeline
- Start date
- 2024-07-16
- Primary completion
- 2027-04-18
- Completion
- 2027-07-18
- First posted
- 2024-05-23
- Last updated
- 2026-02-09
Locations
28 sites across 3 countries: United States, Argentina, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06427395. Inclusion in this directory is not an endorsement.