Clinical Trials Logo
  1. Home
  2. Primary Biliary Cirrhosis
  3. NCT03112681

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

Primary Biliary Cirrhosis Clinical Trial

Official title:
A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )

Clinical Trial 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. 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.

Clinical Trial Description

Study SARO.16.004.02 is a 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. 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. The primary objective is to investigate the effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03112681
Study type Interventional
Source Zydus Therapeutics Inc.
Contact
Status Completed
Phase Phase 2
Start date August 18, 2017
Completion date August 7, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526665 - Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Phase 3
Recruiting NCT02931513 - sCD163 in PBC Patients - Assessment of Treatment Response
Active, not recruiting NCT02924701 - sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Completed NCT02659696 - Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Completed NCT02078882 - Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Phase 4
Completed NCT01389973 - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid Phase 2
Completed NCT01603199 - High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis N/A
Completed NCT01857284 - Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Phase 3
Completed NCT05374200 - Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC) N/A
Recruiting NCT02937012 - Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Phase 3
Completed NCT02376335 - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Phase 2
Recruiting NCT01662973 - Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis Phase 1/Phase 2
Active, not recruiting NCT04751188 - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Phase 3
Recruiting NCT04514965 - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting NCT03668145 - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis N/A
Completed NCT02955602 - Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) Phase 2
Completed NCT02557360 - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis Phase 4
Recruiting NCT01440309 - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Phase 1
Completed NCT01249092 - Pentoxifylline for Primary Biliary Cirrhosis Phase 2
Completed NCT01510860 - Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis Phase 4