This is observational study in subjects with cronic liver due to non-alcoholic liver diease and subjects who are prescribed Heptral for their treatment

Phase 4

Completed

• Conditions: Health Condition 1: null- Cholestasis

• Registration Number: CTRI/2011/12/002191
• Lead Sponsor: Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Chronic liver disease due to non-alcoholic liver

disease as diagnosed by the physician

- Intrahepatic cholestasis as diagnosed by the

physician

- Age 18 to 65 years.

- Patients being prescribed Heptral according to

local label

- Patient?s written authorization to provide data

for the study

Exclusion Criteria

-Contraindications to Heptral treatment including

hypersensitivity according to the local label.

-Pregnancy 1-2 trimester or lactation

-Hepatocellular or metastatic liver carcinoma.

-Severe liver disease including but not limited to

ascites, hepatic encephalopathy, hypoalbuminemia,

coagulopathy

-Other conditions that make the patients

participation impossible (by investigator

judgment)

-Patients receiving any hepatotoxic medications

-Previous enrollment in the present study

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Demographics, underlying liver disease, diagnostic criteria of intrahepatic cholestasis. <br/ ><br> a.Healthcare utilization (during 6 weeks before assessment) <br/ ><br> i.Number of visits to health care service in last 6 weeks due to liver disease <br/ ><br> ii.Number of days in hospital in the last 6 weeks due to liver disease <br/ ><br> <br/ ><br>b.Workload effect (during 6 weeks before assessment) <br/ ><br> i.No. of days off work in the last 6 weeks due to liver disease. <br/ ><br> <br/ ><br>3)Reason(s)for prescribing Heptral. <br/ ><br>Timepoint: All the parameters mentioned above will be assessed at Day 42 ( End of treatment)

Secondary Outcome Measures

Name	Time	Method
. Change from baseline to the end of the observation period of 6 weeks for the following: <br/ ><br> a.Lab parameters (if available) <br/ ><br> i.(STB) <br/ ><br> ii.(SCB) Direct <br/ ><br> iii. (ALP) <br/ ><br> iv.Serum γ-glutamyltranspeptidase (γGT) <br/ ><br> v. (ALT) <br/ ><br> vi. (AST) <br/ ><br> b.Presence of signs and symptoms of cholestasis assessed by the Investigator (jaundice, fatigue, pruritus) <br/ ><br>2.To evaluate the tolerability of Ademetionine during therapy. <br/ ><br>Timepoint: Above will be assessed at the day 42