New Delhi: Suggesting to include more government sites in Phase III Clinical trial protocol, the Central Drugs Standard Control Organization (CDSCO) Committee has asked Abbott to submit a revised protocol for reviewing the additional indication of Ursodeoxycholic Acid Tablets by the committee.
Abbott presented the Phase III Clinical trial protocol before the CDSCO Committee for Ursodeoxycholic Acid Tablets IP 150mg/300mg/450mg/600mg (additional Indication).
Ursodeoxycholic Acid is a hepatoprotective medication. It works by reducing the amount of cholesterol in the blood and helps dissolve gallbladder stones that are composed mainly of cholesterol. It also improves liver enzymes, protects liver cells from injury caused due to toxic bile acids, and improves liver function.
However, the Subject Expert Committee, operative under CDSCO has suggested some revisions such as excluding patients with Hepatitis A & E infection and foetal growth retardation among others.
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The Subject Expert Committee (SEC) in its 35th meeting held on 17.02.2021 at CDSCO HQ New Delhi reviewed the Gastroenterology and Hepatology related proposals. After detailed deliberation the committee recommended to revise the Phase III clinical trial as below:
1. Obstetric ultrasound to be performed for evaluation of foetal growth retardation at the time of enrolment.
2. Patients with Hepatitis A & E infection and foetal growth retardation should be excluded from the study.
3. Dose of the study drug should be clearly defined in the protocol along with criteria for dose titration.
4. More Government sites are to be included.
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Accordingly, the CDSCO panel directed the firm Abbott to submit the revised protocol for review by the committee.
Abbott Laboratories is a global healthcare leader having its roots in America. It has its headquarters in Abbott Park, Illinois, The United States. The company started its journey back in 1888 to formulate known drugs. In the present times, the company is involved in the manufacturing and marketing of medical devices, diagnostics, branded generic medicines, and nutritional products.
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