A phase III study in ICP (intraheptatic cholestatis of pregnancy) to assess the improvement of pruritis and other liver parameters after treatment with Udiliv tablets

Phase 3

• Conditions: Health Condition 1: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium

• Registration Number: CTRI/2021/08/035635
• Lead Sponsor: Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age > 19 years

2.Gestational age of >= 28 weeks at the time of study enrolment but less than or equal to 33 weeks

3.Body weight between 40 kg and 90 kg (both inclusive)

4.Confirmed diagnosis of OC (ICP), which is characterised by consistent pruritus associated with elevated levels of serum transaminases (ALT > 40 U/L or AST > 37 U/L) and raised serum bile acids (>= 10 µmol/L)

5.Able to understand and comply with the requirements of the study, and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed

6.Voluntary informed consent for taking the study drug until their delivery and also willing to be followed until their delivery

7.Agrees to provide the information on perinatal and maternal outcomes at or after delivery

8.Anticipated to require at least 4 weeks of UDCA therapy after inclusion

Exclusion Criteria

1.History or current diagnosis of hepatic viral infections (Hepatitis A, B, C, and E virus related liver diseases, Epstein Barr virus, cytomegalovirus, Herpes simplex virus), human immunodeficiency virus infection, chronic liver diseases like primary biliary cirrhosis, primary sclerosing cholangitis, dermatologic diseases, metabolic diseases like diabetes (including alcohol abuse), other causes of cholestasis, eclampsia, acute fatty liver of pregnancy, autoimmune liver disease, obstructive hepatobiliary disease, calcified stones, gall bladder disease, inflammatory bowel disease, skin diseases, allergic reactions, haematological disorders or other disorders that may cause pruritus or elevated levels of bile and serum aminotransferases

2.Any other conditions or diseases that Investigator considers as inappropriate for a patient to participate in the study

3.History of any relevant allergy or hypersensitivity to the study drug or its excipients

4.Obstetric ultrasonography suggestive of fetal growth restriction/ abnormalities

5.High risk pregnancies. For, eg, multiple pregnancies, advanced maternal age, etc.

6.Willing to continue taking the prohibited medication(s), including bile acid sequestering agents like cholestyramine and colestipol, antacids containing aluminium hydroxide or aluminium oxide, and drugs affecting lipid metabolism like oestrogens, oral contraceptives, and lipid-lowering drugs like bezafibrate, clofibrate, ciprofibrate during the conduct of the study

7.Not able or not willing to attend the visits or follow the procedures according to the protocol

8.Subjects who are determined as being the risk group for COVID-19 as per applicable national guidelines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified