Heptral Observational study in patient with Alcoholic Liver Disease
- Conditions
- Health Condition 1: null- Alcoholic Liver Disease with Intra Hepatic Cholestasis
- Registration Number
- CTRI/2011/12/002253
- Lead Sponsor
- Abbott India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
1)Chronic liver disease due to alcoholic liver disease as diagnosed by the physician
2)Intrahepatic cholestasis as diagnosed by the physician
3)Age 18 to 65 years.
4)Patients being prescribed Heptral according to local label.
5)Patient?s written authorization to provide data for the study.
1)Contraindications to Heptral treatment including hypersensitivity according to the local label.
2)Pregnancy 1-2 trimester or lactation.
3)Hepatocellular or metastatic liver carcinoma.
4)Severe liver disease including but not limited to ascites, hepatic encephalopathy, hypoalbuminemia, coagulopathy.
5)Other conditions that make the patients participation impossible (by investigator judgment).
6)Patients receiving any hepatotoxic medications
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Demographic data underlying liver disease, diagnostic criteria of intrahepatic cholestasis. <br/ ><br>2. Burden of disease in terms of Healthcare utilization & Workload effect <br/ ><br>3. Reason(s) for prescribing HeptralTimepoint: After 6 weeks of therapy
- Secondary Outcome Measures
Name Time Method To better understand the effectiveness and the tolerability of ademetionine therapy in the patient population with cholestasis in chronic liver disease due to alcoholic liver disease.Timepoint: 6 weeks treatment