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

Join our study on Saroglitazar Magnesium for Primary Biliary Cholangitis.

Recruiting
18 years and older
All
Phase 3
Study Summary

Study Purpose: This study is for people with Primary Biliary Cholangitis (PBC), a liver disease where the bile ducts in the liver are slowly destroyed. Scientists want to see if a medicine called Saroglitazar Magnesium is safe and works well for these patients.

Important Points:

  • The study is open-label, meaning both the patients and doctors know what treatment is being given. This is an extension, so only those who completed a previous study (SARO.21.001) can join.
  • Participants must follow strict rules, such as not drinking too much alcohol and not having certain other diseases.
  • The study excludes people with severe liver problems, uncontrolled heart issues, or recent surgeries.

Things to Remember:

  • If you have any other liver diseases or conditions, you might not be able to join.
  • Participants need to agree not to get pregnant during the study.
  • If you have allergies to the study medicine, you cannot participate.
Study details
    Primary Biliary Cholangitis

NCT06427395

Zydus Therapeutics Inc.

9 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

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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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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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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