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Clinical Trials/CTRI/2021/08/035635
CTRI/2021/08/035635
Recruiting
Phase 3

A Phase III, Prospective Multicentric, Clinical Study in the Management of Pregnancy Induced Cholestasis to Evaluate the Efficacy and Safety of Ursodeoxycholic Acid (Udiliv) Tablets [PICTURE Study]. - PICTURE STUDY

Abbott India Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium
Sponsor
Abbott India Limited
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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