To evaluate the safety and efficacy of Saroglitazar 4 mg in thetreatment of Alcoholic Liver Disease.
Phase 2
- Conditions
- Alcoholic liver disease, unspecified,
- Registration Number
- CTRI/2019/08/020846
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Alcoholic liver disease (ALD) comprises a clinical-histologic spectrum including fatty liver,
alcoholic hepatitis (AH), and cirrhosis with its complications. This condition develops in persons
with a history of prolonged and heavy alcohol use. A number of therapies have been assessed for the
treatment of ALD, but only two drugs (Prednisolone and Pentoxifylline) have been incorporated into
the treatment guidelines published by the American Association for the Study of Liver Disease and
the European Association for the Study of the Liver. Thus, there is a need to develop a treatment
which will provide effective therapy to patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 60
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
- 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.
- 8)Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Change in the following grades of FibroMax Test at 12 and 24 weeks [Timeframe: 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. baseline, 12 and 24 weeks]. 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. a) Fibro Test (for hepatic fibrosis). 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. c) Ash Test (for alcoholic steatohepatitis). 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. b) Steato Test (for hepatic steatosis). 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. 3. Change in Maddrey Discriminant function (DF) at 6, 12 and 24 weeks. 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. 5. Change in AST levels at 6, 12 and 24 weeks. 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. 6. Change in ALT levels at 6, 12 and 24 weeks. 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. 2. Change in MELD score at 6, 12 and 24 weeks. 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. 4. Change in GGT levels at 6, 12 and 24 weeks. 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 Outcome Measures
Name Time Method Frequency and severity of AEs and serious AEs. 2. Alteration in laboratory parameters.
Trial Locations
- Locations (6)
Apex Hospital Pvt. Ltd
🇮🇳Jaipur, RAJASTHAN, India
Ashirwad Hospital and Research Centre
🇮🇳Thane, MAHARASHTRA, India
Dr. Vasantrao Pawar Centre For Developmental Therapeutics Translational Research
🇮🇳Nashik, MAHARASHTRA, India
Institute of Medical Science and SUM Hospital
🇮🇳Khordha, ORISSA, India
Peerless Hospitex Hospital And Research Center Limited
🇮🇳Kolkata, WEST BENGAL, India
SRM Institute of Medical Science (SIMS Hospital)
🇮🇳Chennai, TAMIL NADU, India
Apex Hospital Pvt. Ltd🇮🇳Jaipur, RAJASTHAN, IndiaDr Mohan GoyalPrincipal investigator8432432000mohandr77@gmail.com