Saroglitazar 4 mg in Patients with Liver Disease.

Phase 3

Completed

• Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 2: null- NonalcoholicFatty Liver Disease

• Registration Number: CTRI/2017/11/010511
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1.Males or females, 18 to 65 years of age.

2. Diagnosis of NAFLD established either by imaging [ultrasound, computed tomography

(CT) scan or magnetic resonance imaging (MRI)] or liver biopsy showing simple

steatosis, within 6 months of the Screening Phase for this study. The diagnosis of

NAFLD is made according to the American Association for the Study of Liver Diseases

(AASLD) criteria (Chalasani et al. Hepatology 2012; 55:2005-2023).

(a) hepatic steatosis by imaging or histology,

(b) no significant alcohol consumption,

(c) no competing etiologies for hepatic steatosis, and

(d) no co-existing causes for chronic liver disease.

3. Patients with steatosis >= 10 % as assessed by MRI at the Screening.

4. ALT level of >= 1.5 Ã? ULN at screening.

5. Patientâ??s demonstration of understanding of study requirements and treatment

procedures, willingness to comply with all protocol-required evaluations; provision of

written informed consent form before any study specific tests or procedures are

performed.

Exclusion Criteria

1.Use of vitamin E ( >400 IU/day) or multivitamins containing vitamin E ( >400 IU/day)

in the 3 months preceding enrollment.

2.Use of drugs with potential effect on NAFLD/NASH such as ursodeoxycholic acid,

S-adenosylmethionine (SAM-e), betaine, pentoxifylline 1 month prior to enrollment.

3.Fibrates (clofibrate, fenofibrate) in the 3 months prior enrollment.

4.Use of thiazolidinedione (pioglitazone, rosiglitazone).

5.History of bowel surgery (gastrointestinal (bariatric) surgery or undergoing

evaluation for bariatric surgery for obesity, extensive small-bowel resection, or

orthotopic liver transplant (OLT) or listed for OLT.

6.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis,

cholestatic and metabolic liver diseases) and hemochromatosis.

7.Patient has known cirrhosis, either based on clinical criteria or liver histology or

Fibroscan®.

8.Patient with International normalized ratio (INR) >1.3.

9.Type 1 diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified