NCT03112681 - Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 18, 2017

Primary Completion Date

August 7, 2020

Study Completion Date

August 7, 2020

Conditions

Primary Biliary Cirrhosis

Interventions

DRUG

Saroglitazar magnesium 2 mg

Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.

DRUG

Saroglitazar magnesium 4 mg

Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.

DRUG

Placebo Oral Tablet

Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.

Trial Locations (9)

Hospital of the University of Pennsylvania, Philadelphia

Einstein Medical Center Philadelphia, Philadelphia

Carolinas Healthcare System, Charlotte

Gastrointestional Specialists of Georgia, Marietta

Schiff Center for Liver Diseases/University of Miami, Miami

Consultants for Clinical Research, Cincinnati

Indiana University School of Medicine, Indianapolis

California Liver Research Institute, Pasadena

Rutgers NJ Medical School, Newark

All Listed Sponsors

lead

Zydus Therapeutics Inc.

INDUSTRY