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PPAR agonist
Saroglitazar Magnesium for Primary Biliary Cirrhosis
Phase 3
Recruiting
Research Sponsored by Zydus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
History or presence of other concomitant liver diseases at screening: Chronic hepatitis B or C virus (HBV, HCV) infection, Primary sclerosing cholangitis (PSC), Alcoholic liver disease, Autoimmune hepatitis (AIH)-PBC overlap syndrome, Hemochromatosis, Non-alcoholic steatohepatitis (NASH) on historical biopsy, Cirrhosis with complications, Use of Thiazolidinediones or Fibrates, Use of Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids, History of bowel surgery, Unstable cardiovascular disease, An uncontrolled thyroid disorder, History of myopathies or evidence of active muscle disease, Abnormal laboratory values, Participation in another interventional clinical study, History of malignancy, Known allergy, sensitivity or intolerance to the study medication or formulation ingredients, Pregnancy-related exclusions, History or other evidence of severe illness or any other conditions that would make the participant unsuitable for the study, Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening
Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to months 12 and 24/eot
Awards & highlights
Summary
"This trial is an open-label study that will look at the effects of Saroglitazar Magnesium in people with Primary Biliary Cholangitis."
Who is the study for?
This trial is for individuals who have completed the SARO.21.001 study on primary biliary cholangitis and agreed to follow the protocol. They must not be heavy drinkers, have a MELD score under 15, or suffer from other liver diseases, unstable heart disease, uncontrolled thyroid issues, muscle diseases, or severe illnesses.
What is being tested?
The trial tests Saroglitazar Magnesium at a dose of 1 mg in patients with primary biliary cholangitis. It's an open-label extension which means everyone knows they're getting the actual drug and there's no placebo involved.
What are the potential side effects?
While specific side effects are not listed here, common ones for similar medications may include digestive issues, potential liver enzyme changes, muscle pain or weakness, and possible cardiovascular events.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been drinking no more than the daily limit for my gender for the past 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to months 12 and 24/eot
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to months 12 and 24/eot
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Effect on disease-related symptoms
Effect on lipid parameters
Effect on liver enzyme parameters
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Saroglitazar Magnesium 1 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
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Who is running the clinical trial?
Zydus Therapeutics Inc.Lead Sponsor
14 Previous Clinical Trials
1,201 Total Patients Enrolled
Deven ParmarStudy DirectorZydus Therapeutics Inc.
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