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Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

NCT03112681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-09-19

Study results available
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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.

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.

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven Parmar, MD FACP FCP · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2020-08-07
Completion
2020-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112681 on ClinicalTrials.gov