RecruitingPrimary Biliary Cholangitis
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Sponsor: Zydus Therapeutics Inc.
You may qualify if…
- ✓ Each participant must meet all of the following criteria to be enrolled in this study:
- ✓ 1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements
- ✓ 2. Is an adult male or female, must be ≥18 years of age at the time of signing informed consent
- ✓ 3. Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA in the past 3 months prior to screening
- ✓ 4. Has a history of confirmed PBC diagnosis, as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
- ✓ i. A history of elevated ALP levels for ≥6 months prior to screening ii. Positive antimitochondrial antibodies (AMA) titer OR if AMA is negative, then positive PBC-specific antibodies iii. Liver biopsy consistent with PBC diagnosis
- ✓ 5. Has documented evidence of cirrhosis and has ALP \>ULN and TB ≤5 × ULN
You may not qualify if…
- ✕ Participants meeting any of the following criteria will be excluded from the study:
- ✕ 1. Has consumption of 2 standard alcohol drinks per day (or 14 alcohol drinks per week) if male and 1 standard alcohol drink per day (or 7 alcohol drinks per week) if female for ≥3 consecutive months (12 consecutive weeks) within 5 years prior to screening
- ✕ 2. Has known CPT B (having a score of ≥7) or CPT C (having a score of ≥10) cirrhosis classification at screening
- ✕ 3. Has a Model for End-Stage Liver Disease (MELD)-Na score of ≥12 at screening
- ✕ 4. Has a history or presence of any of the following other concomitant liver diseases at screening:
- ✕ i. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: If a participant has been treated for the HCV infection and has been cured for a duration of \>2 years prior to screening, they can be enrolled in the study. Participants who have seroconverted (hepatitis B surface antigen-negative and hepatitis B surface antibody-positive) may be included in this study.
- ✕ ii. Primary sclerosing cholangitis iii. Alcohol-associated liver diseases iv. Autoimmune hepatitis (AIH)-PBC overlap syndrome v. Hemochromatosis vi. Metabolic dysfunction-associated steatohepatitis on historical biopsy vii. α-1 antitrypsin deficiency
- ✕ 5. Has a history or presence of clinically significant hepatic decompensation, including the following:
Where it's recruiting
Source: ClinicalTrials.gov · NCT07216235 · last updated 2026-08-04