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

A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Non-Alcoholic Liver Disease Receiving Heptral in India - SAMe NALD PMOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2011/12/002191

Enrollment

250

Registered

2011-12-02

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- Cholestasis

Interventions

Intervention1: Heptral: Heptral will be prescribed as per local label. Recommendation of the dosage is purely as per discretion of the inverstigator. As per the local label dosage can vary from 400 m

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
. Change from baseline to the end of the observation period of 6 weeks for the following: a.Lab parameters (if available) i.(STB) ii.(SCB) Direct iii. (ALP) iv.Serum Î³-glutamyltranspeptidase (Î³GT) v. (ALT) vi. (AST) b.Presence of signs and symptoms of cholestasis assessed by the Investigator (jaundice, fatigue, pruritus) 2.To evaluate the tolerability of Ademetionine during therapy. Timepoint: Above will be assessed at the day 42	—

Measure

Time frame

. Change from baseline to the end of the observation period of 6 weeks for the following: a.Lab parameters (if available) i.(STB) ii.(SCB) Direct iii. (ALP) iv.Serum Î³-glutamyltranspeptidase (Î³GT) v. (ALT) vi. (AST) b.Presence of signs and symptoms of cholestasis assessed by the Investigator (jaundice, fatigue, pruritus) 2.To evaluate the tolerability of Ademetionine during therapy. Timepoint: Above will be assessed at the day 42

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Countries

India

Contacts

Public ContactDrVGMohan Prasad

VGM Hospital institute of gastroenterology

drvgm@rediffmail.com09842204995

Outcome results

None listed

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