Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA): protocol for a randomised, double-blind, placebo-controlled trial of enhanced primary therapy with obeticholic acid

This is a Pre-Registered Trial study.

Key Points

To assess the efficacy and safety of obeticholic acid as enhanced primary therapy for primary biliary cholangitis.
Randomised, double-blind, placebo-controlled design
Inclusion of patients with primary biliary cholangitis
Enhanced primary therapy using obeticholic acid compared to placebo
Focus on evaluating the effectiveness of obeticholic acid
Potential improvement in patient outcomes
Assessment of safety and tolerability during the trial

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Randomised trial examines obeticholic acid in patients with primary biliary cholangitis, suggesting improvement in therapy outcomes.

Isrctn17176388.

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Dunn et al. (2026) studied this question.

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