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Heptral Observational study in patient with Alcoholic Liver Disease

A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Alcoholic liver disease receiving Heptral in India. - ALD PMOS SAMe

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/12/002253
Enrollment
250
Registered
2011-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Alcoholic Liver Disease with Intra Hepatic Cholestasis

Interventions

Intervention1: Heptral: Generic Name: Ademetionine or S-adenosyl-L-methionine Dose & Frequency: As per approved labeled recommendations Duration: Minimum of 6 weeks, can be extended if required base

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1. Demographic data underlying liver disease, diagnostic criteria of intrahepatic cholestasis. 2. Burden of disease in terms of Healthcare utilization & Workload effect 3. Reason(s) for prescribing HeptralTimepoint: After 6 weeks of therapy

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Tina Singh

Abbott India Limited

tina.singh@abbott.com02267978877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026