New Delhi: Abbott India has been granted approval by the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) to proceed with a Phase III clinical trial of Ursodeoxycholic Acid (UDCA) tablets in dosages of 150 mg, 300 mg, 450 mg, and 600 mg. This decision came after Abbott India presented a revised Phase III clinical trial protocol, incorporating changes as suggested by the committee.
Ursodeoxycholic Acid is utilized in the treatment of primary biliary cirrhosis (PBC), a chronic liver disease. It functions by protecting liver cells from damage caused by bile acids, reducing inflammation, and preventing oxidative stress within the liver.
Last year, the SEC had requested Abbott India to revise the trial protocol concerning several points:
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Definition of Normal ALT Values: The firm was instructed to define normal ALT (alanine aminotransferase) levels for both genders and to compare the normalization of ALT levels between the placebo and test groups. Additionally, the reduction in ALT levels was to be expressed as a percentage decrease from baseline.
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Redefinition of Study Objectives: The primary and secondary objectives of the study were to be redefined to ensure clinically meaningful outcomes. This included incorporating fibroscan investigations at baseline and after six months, alongside the normalization of ALT values as endpoints.
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Sample Size Calculation: The sample size was to be calculated based on a single dose compared to a placebo and adjusted according to credible studies to reinforce the study's objectives.
Following these revisions, Abbott India presented the updated protocol at the SEC meeting for Gastroenterology and Hepatology on December 12, 2024. After thorough deliberation, the committee endorsed the conduct of the Phase III clinical trial as per the revised protocol presented by Abbott India.
