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Title: A PHASE III, PROSPECTIVE MULTICENTRIC STUDY IN MANAGEMENT OF PREGNANCY INDUCED CHOLESTASIS TO EVALUATE THE EFFICACY AND SAFETY OF UDCA
e-poster Number: EP 167
Category: Maternal and Fetal Health
Author Name: Dr. Pikee Saxena
Institute: Lady Hardinge Medical College
Co-Author Name:
Abstract :
Introduction ICP, the most common liver disorder of pregnancy in India, characterized by elevated serum bile acids, serum aminotransferases levels, persistent pruritus, and fetal complications risk, has no approved therapy currently. Aims and Objectives Primary- To evaluate the efficacy of UDCA in reduction of pruritus intensity using VAS at 2weeks. Secondary? To evaluate reduction in pruritus, serum bile acid, transaminases, GGT, and bilirubin levels from baseline until time of delivery and safety. Material and Methods This was a prospective, multicenter, open-label, single-arm, Phase III clinical trial. 15 centers across India enrolled 120 women at gestational age of ?22 weeks ?35 weeks with confirmed diagnosis of ICP - consistent pruritus associated with elevated levels of serum transaminases (ALT >40 U/L or AST >37 U/L), raised serum bile acids (?10 ?mol/L), anticipated to require at least 4 weeks of UDCA. UDCA 300 mg/450 mg was administered orally with water (after meals) in three divided doses until delivery. Results The change in score from baseline was -22.6, which was highly statistically significant (p-value <0.0001) indicating UDCA is effective in reducing intensity of pruritus over a 2-week treatment period. This reduction was maintained in subsequent visits. Secondary endpoints showed statistically significant reduction from baseline in serum bile acid, ALT, AST, GGT and bilirubin level at delivery. Most TEAEs were mild in severity, not related to study drug and not requiring discontinuation. 5 SAEs reported 1 was related to study drug. Conclusions Study findings demonstrate that treatment with UDCA in subjects with ICP is efficacious in reducing pruritus intensity and improving liver function parameters while being generally safe and well-tolerated. Conflict of Interest: There is no conflict of interest declared by the author Financial Support: The research was funded by Abbott India Ltd