Health Condition 1: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Ursodeoxycholic acid tablets (300/450 mg: Each uncoated tablet contains Ursodeoxycholic acid I.P. The starting dose of the study would be 300 mg TID. If there is an increasing trend in
Sponsors
Abbott India Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is change in the intensity of pruritus from baseline to Week 2 of therapy initiation on 100 mm VAS ranging from score 0 mm (no pruritus at all) to 100 mm (worst possible pruritus)Timepoint: The primary endpoint of the study is change in the intensity of pruritus from baseline to Week 2 of therapy initiation on 100 mm VAS ranging from score 0 mm (no pruritus at all) to 100 mm (worst possible pruritus) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Ursodeoxycholic Acid (Udiliv) treatment on the following pregnancy outcomes at deliveryTimepoint: At delivery;Change in the intensity of pruritus from baseline until the time of delivery (at 2-week intervals) on 100 mm VAS ranging from score 0 mm (no pruritus at all) to 100 mm (worst possible pruritus)Timepoint: baseline until the time of delivery (2 weeks interval);Relative reduction in serum ALT, AST, GGT, and bilirubin levels from baseline until the time of delivery(at 4-week intervals) â?¢ Number (percentage) of patients requiring rescue medications (hydroxyzine or diphenhydramine or any other antihistamines) for pruritus â?¢ Average gestational age (days) at baseline â?¢ Mean total duration (days) of Ursodeoxycholic Acid (Udiliv) treatment Timepoint: baseline until the time of delivery(at 4-week intervals) ;Relative reduction in serum total bile acids from baseline until the time of delivery (at 2-week intervals)Timepoint: baseline until the time of delivery (2-week intervals);Safety Endpoints â?¢ Number and proportion of patients with respect to TEAEs/SAEs â?¢ Changes in physical examination findings or obstetric findings from baseline until delivery â?¢ Changes in vital signs from baseline until delivery Timepoint: baseline until delivery | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Limited
Outcome results
None listed