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Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

Study on Saroglitazar Magnesium-V's safety for Primary Biliary Cholangitis.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study looks at a new treatment for people with Primary Biliary Cholangitis (PBC), a liver disease. The study checks if the drug *Saroglitazar Magnesium-V* is safe and works well. PBC is when the liver's bile ducts get damaged, causing liver problems. The study is "double-blind," meaning neither the doctors nor the participants know who gets the real drug or a placebo (fake treatment). The study is "placebo-controlled" to compare the new treatment's effects against no treatment.

To join, you must be 18 or older and have PBC. You should be taking a medicine called *Ursodeoxycholic Acid (UDCA)* for at least 12 months or not tolerate it. You also need to have a history of PBC confirmed by tests.

  • The study is long-term, meaning it takes a while to complete.
  • Participants must attend multiple study visits over time.
  • There might be some risks or side effects from the treatment.
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Study details
    Primary Biliary Cholangitis

NCT07216235

Zydus Therapeutics Inc.

17 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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