Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride

Criteria

Inclusion Criteria:

1. Age at entry at least 18 years.

2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.

3. Evidence of hepatic steatosis or liver fat (>5%) by MRI.

4. Evidence of definite or suspected NASH

5. Written informed consent.

Exclusion criteria:

1. Evidence of another form of liver disease.

2. History of excess alcohol ingestion.

3. Contraindications to liver biopsy.

4. Decompensated liver disease.

5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.

6. Recent initiation or change of anti-diabetic drugs.

7. Use of colesevelam or other agents in the same class.

8. Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.

9. Positive test for anti-HIV.

10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.

11. Pregnancy or inability to practice adequate contraception in women of childbearing potential.

12. Evidence of hepatocellular carcinoma