New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has accepted Abbott’s phase III clinical trial protocol amendment proposal for Ursodeoxycholic Acid Tablets IP 150 mg, 300 mg, 450 mg, and 600 mg with respect to inclusion and exclusion criteria.
Ursodeoxycholic acid, or ursodiol, is a naturally occurring bile acid that is used to dissolve cholesterol gallstones and to treat cholestatic forms of liver diseases, including primary biliary cirrhosis.
This approval came after the firm presented its proposal for amendment in the Phase III clinical trial protocol (No. UDIL3002, version 4, dated 26.07.2022) with respect to inclusion and exclusion criteria like the inclusion of patients with the gestational age of ≥ 22 weeks at the time of study enrollment but less than or equal to 35 weeks instead of the inclusion of patients with the gestational age of ≥ 28 weeks at the time of study enrollment but less than or equal to 33 weeks.
Ursodeoxycholic acid is a hydrophilic bile acid that mediates its biological effects via several mechanisms. Ursodeoxycholic acid (UDCA) protects hepatocytes and cholangiocytes from bile acid-induced damage, such as reactive oxygen species (ROS)-induced inflammation and mitochondrial dysfunction. UDCA was shown to reserve hepatocyte cell structures and stimulate anti-apoptotic pathways. It was also shown to prevent the production of ROS by Kupffer cells and resident macrophages in the liver, thus attenuating oxidative stress in the liver.
Ursodeoxycholic acid is indicated for the treatment of patients with primary biliary cholangitis. It is used for the short-term treatment of radiolucent, noncalcified gallbladder stones in patients selected for elective cholecystectomy. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.
At the recent SEC meeting for Gastroenterology and Hepatology held on the 16th and 17th of March 2023, the expert panel reviewed the proposal presented by the drug major Abbott for the amendment in Phase III clinical trial protocol (No. UDIL3002, version 4, dated 26.07.2022) with respect to inclusion and exclusion criteria like the inclusion of patients with the gestational age of ≥ 22 weeks at the time of study enrollment but less than or equal to 35 weeks, instead of the inclusion of patients with the gestational age of ≥ 28 weeks at the time of study enrollment but less than or equal to 33 weeks
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the amended protocol presented by the firm.
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