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Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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 )

NCT03112681•Zydus Therapeutics Inc.

View on ClinicalTrials.gov

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.

Detailed 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 alkaline phosphatase (ALP) levels in patients with Primary Biliary Cholangitis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females, between 18 and 75 years of age, inclusive.
•2. a) Patients on therapeutic doses of Ursodeoxycholic acid (UDCA) for ≥12 months and stable therapy for ≥3 months prior to enrolment.
•OR b) Patients who are unable to tolerate UDCA, and did not receive UDCA for at least 3 months from the date of screening.
•3. History of confirmed Primary Biliary Cholangitis Diagnosis, based on American Association for the Study of Liver Disease \[AASLD\] and European Association for Study of the Liver \[EASL\] Practice Guidelines; \[Lindor 2009; EASL 2009\], as demonstrated by the presence of at least≥2 of the following 3 diagnostic factors:
•* History of elevated Alkaline Phosphatase levels for at least 6 months prior to Screening Visit 1
•* Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components \[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex\])
•* Liver biopsy consistent with PBC.
•4. ALP ≥1.67x upper limit of normal (ULN) at Visit 1 and Visit 2 and with \< 30% variance between the levels from Visit 1 to Visit 2.
•5. Contraception: Female patients must be postmenopausal, surgically sterile, or if premenopausal, agree to use ≥ 1 effective method of contraception during the trial. Effective methods of contraception are considered to be Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection); or Double barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide; or Intrauterine device (IUD); or Vasectomy (partner).
•6. Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria

•1. Consumption of \>3 units of alcohol per day (\>21 units per week) if male and \>2 units of alcohol per day (\>14 units per week) if female for at least 3 consecutive months in the last 5 years (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
•2. History or presence of other concomitant liver diseases including:
•* Hepatitis B or C virus (HCV, HBV) infection
•* Primary sclerosing cholangitis (PSC)
•* Alcoholic liver disease
•* Definite autoimmune liver disease or overlap syndrome
•* Non-alcoholic steatohepatitis (NASH)
•3. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin \> 2x ULN, ascites, encephalopathy, known esophageal varices or history of variceal bleeding and active or history of hepatorenal syndrome.
•4. History of any venous thromboembolism, transient ischemic attack (TIA), intracranial hemorrhage, neoplasm, arteriovenous malformation, vasculitis, bleeding disorder, coagulation disorders or screening blood tests that indicate altered coagulability (e.g. platelet count, activated partial thromboplastin time \[aPTT\], partial thromboplastin time \[PTT\] or thrombin time \[TT\] tests).
•5. Patients with INR \> upper limit of normal (ULN) at visit 1.
+15 more criteria

Locations (9)

California Liver Research Institute

Pasadena, California, United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States

Gastrointestional Specialists of Georgia

Marietta, Georgia, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Rutgers NJ Medical School

Newark, New Jersey, United States

Carolinas Healthcare System

Charlotte, North Carolina, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 18, 2017

Primary Completion Date

August 7, 2020

Completion Date

August 7, 2020

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cirrhosis

Interventions

Saroglitazar magnesium 2 mg

DRUG

Saroglitazar magnesium 4 mg

DRUG

Placebo Oral Tablet

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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