To evaluate the safety and efficacy of Saroglitazar 4 mg in thetreatment of Alcoholic Liver Disease.

Phase 2

• Conditions: Health Condition 1: K709- Alcoholic liver disease, unspecified

• Registration Number: CTRI/2019/08/020846
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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.

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.

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: <br/ ><br>baseline, 12 and 24 weeks]. <br/ ><br>a) Fibro Test (for hepatic fibrosis). <br/ ><br>b) Steato Test (for hepatic steatosis). <br/ ><br>c) Ash Test (for alcoholic steatohepatitis). <br/ ><br>2. Change in MELD score at 6, 12 and 24 weeks. <br/ ><br>3. Change in Maddrey Discriminant function (DF) at 6, 12 and 24 weeks. <br/ ><br>4. Change in GGT levels at 6, 12 and 24 weeks. <br/ ><br>5. Change in AST levels at 6, 12 and 24 weeks. <br/ ><br>6. Change in ALT levels at 6, 12 and 24 weeks.Timepoint: 1)Timeframe:baseline, 12 and 24 weeks <br/ ><br>2. at 6, 12 and 24 weeks. <br/ ><br>3. at 6, 12 and 24 weeks. <br/ ><br>4. at 6, 12 and 24 weeks. <br/ ><br>5. at 6, 12 and 24 weeks. <br/ ><br>6. at 6, 12 and 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of AEs and serious AEs. <br/ ><br>2. Alteration in laboratory parameters. <br/ ><br>3. Twelve-lead electrocardiogram. <br/ ><br>4. Vital signs. <br/ ><br>5. Physical examination.Timepoint: All visit