Heptral Observational study in patient with Alcoholic Liver Disease

Not Applicable

Completed

Brief Summary: In xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India, ademetionine (Heptral) is approved for the management of intrahepatic cholestasis and liver diseases. While ademetionine (Heptral) has been available since the past few months in the Indian market, there is limited information on its effectiveness in Indian patients with ALD in terms of improvement in hepatic function profile as well as regarding its safety, tolerability and compliance amongst Indian patients. Also, no data currently exist that characterize patient population with chronic liver disease due to alcoholic liver disease to whom Heptral is prescribed in India and there is limited understanding of the physician’s decision making process at the start the of Heptral treatment. Hence this observational study was planned to include Indian patients with ALD who had been prescribed Heptral by their physicians, in accordance with dosing recommendations mentioned in Heptral package insert, with the objective to gain insight into effectiveness, safety-tolerability and compliance of the drug.

This is a non-interventional, prospective observational study in which Heptralis prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
1. Demographic data underlying liver disease, diagnostic criteria of intrahepatic cholestasis.	After 6 weeks of therapy
2. Burden of disease in terms of Healthcare utilization & Workload effect	After 6 weeks of therapy
3. Reason(s) for prescribing Heptral	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.	6 weeks treatment

Locations (21): Andhra Hospitals
🇮🇳
Krishna, ANDHRA PRADESH, India
Apex Hspitals Pvt Ltd
🇮🇳
Jaipur, RAJASTHAN, India
Ashwini Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
C.N. Gastrocare & Smile Dental Centre
🇮🇳
Nagar, UTTAR PRADESH, India
City Diagnostic Center
🇮🇳
East, SIKKIM, India
Gadhikars Clinic
🇮🇳
Pune, MAHARASHTRA, India
Gastro Care
🇮🇳
Delhi, DELHI, India
Gastroenterology and Endoscopy Center
🇮🇳
Nagpur, MAHARASHTRA, India
Gem Hospital & Research Center
🇮🇳
Coimbatore, TAMIL NADU, India
Global Hospitals & Health City
🇮🇳
Chennai, TAMIL NADU, India
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Andhra Hospitals
🇮🇳Krishna, ANDHRA PRADESH, India
Dr Sateesh Javvaji
Principal investigator
9951266448
drjavvaji@gmail.com