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Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Join an open study of Saroglitazar Magnesium for liver condition research.

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

This study is for people with **Primary Biliary Cholangitis (PBC)**, a liver disease where bile ducts in the liver are damaged. Researchers want to see if a medicine called **Saroglitazar Magnesium** helps. The study is open-label, meaning everyone knows what they’re getting. To join, you must have finished an earlier study (SARO.21.001). People with certain health issues like other liver diseases, certain heart problems, or those who drink a lot of alcohol cannot join. Participants cannot use certain medicines before the study. You also cannot join if you are pregnant or have certain severe illnesses.

  • **Study Length**: Specific duration not mentioned, but follow-up is needed.
  • **Visits Needed**: Depends on the study protocol.
  • **Compensation**: Not specified.

If you’re interested, it’s important to talk to your doctor to see if this study is right for you and if you meet all the requirements. They’ll help you understand the benefits and risks of participating.

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Study details
    Primary Biliary Cholangitis

NCT06427395

Zydus Therapeutics Inc.

31 May 2025

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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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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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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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