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

No Placebo-Only Group

Pivotal Trial

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to months 12 and 24/eot for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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).

0 / 2Eligibility criteria met