Case Study

Quality Trial Study Design For Phase II For Primary Biliary Cholangitis Improves Enrollment

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Primary biliary cholangitis (PBC), previously called primary biliary cirrhosis, is a liver disease caused by auto-immune attack on bile duct cells leading to their gradual destruction and eventual disappearance.

PBC is a progressive disease in most patients and may lead to liver cirrhosis and failure. It eventually becomes irreversible, and therefore untreatable.

Challenges

The only widely accepted treatment is Ursodeoxycholic Acid (UDCA), which can delay disease progression and improve long-term survival but does not address the underlying disease.

The response to UDCA, the standard therapy for PBC, is unfortunately not uniformly effective and many patients still experience significant toxicities.

Therefore, there is an ongoing unmet need for improved and more well-tolerated therapies to address additional components of the disease.

The team at Cmed drew on their expertise to contribute to the study design and selection of appropriate endpoints for a Phase II trial with a European Pharmaceutical company.

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