Health Condition 1: K709- Alcoholic liver disease, unspecified
Conditions
Interventions
Intervention1: Saroglitazar: 4 mg tablet Oral OD
Duration 24 weeks
Control Intervention1: Placebo: Placebo tablet Oral OD
Duration 24 weeks
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Heavy alcohol consumption (defined as >20 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment). 2)Should meet the following criteria in the FibroMax test: 2a) Fibro Test (for hepatic fibrosis): Grades F1, F2 and F3. 2b) Steato Test (for hepatic steatosis): Grades S1 and S2. 2c) Ash Test (for alcoholic steatohepatitis): Grades H1 and H2. 3)Ability to understand and give informed consent for participation
Exclusion criteria
Exclusion criteria: 1)Patients with severe alcoholic liver disease as determined by the following criteria: a) Maddrey discriminant function (DF) score more than 32. b) Model for end stage liver disease (MELD) score >=14 2)Will be excluded if the patient meets the following criteria in the FibroMax test. 2a) Fibro Test (for hepatic fibrosis):Grades F0 and F4. 2b) Steato Test (for hepatic steatosis): Grades S0 and S3. 2c) Ash Test (for alcoholic steatohepatitis): Grades H0 and H3. 3)Severe renal impairment (Estimated glomerular filtration rate below 60 ml/min per 1.73m2). 4)Uncontrolled upper gastrointestinal tract bleeding. 5)AST and ALT values more than 400 IU/L. 6)Participants on hepatotoxic medications like antitubercular medication, antiviral medication, etc. 7)Pregnant, attempting to conceive, or lactating women. 8)Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in the following grades of FibroMax Test at 12 and 24 weeks [Timeframe: baseline, 12 and 24 weeks]. a) Fibro Test (for hepatic fibrosis). b) Steato Test (for hepatic steatosis). c) Ash Test (for alcoholic steatohepatitis). 2. Change in MELD score at 6, 12 and 24 weeks. 3. Change in Maddrey Discriminant function (DF) at 6, 12 and 24 weeks. 4. Change in GGT levels at 6, 12 and 24 weeks. 5. Change in AST levels at 6, 12 and 24 weeks. 6. Change in ALT levels at 6, 12 and 24 weeks.Timepoint: 1)Timeframe:baseline, 12 and 24 weeks 2. at 6, 12 and 24 weeks. 3. at 6, 12 and 24 weeks. 4. at 6, 12 and 24 weeks. 5. at 6, 12 and 24 weeks. 6. at 6, 12 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of AEs and serious AEs. 2. Alteration in laboratory parameters. 3. Twelve-lead electrocardiogram. 4. Vital signs. 5. Physical examination.Timepoint: All visit | — |
Countries
India
Contacts
Public ContactDr Manjunath K
Cadila Healthcare Limited
Outcome results
None listed