Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT01066364

Run by

University of California, San Diego

People needed

59

Starts

2010-02-01

Expected to finish

2012-02-01

Last updated by the study team

2020-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age at entry at least 18 years.
• 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.
• Evidence of hepatic steatosis or liver fat (>5%) by MRI.
• Evidence of definite or suspected NASH
• Written informed consent.

You may not qualify if…

• Evidence of another form of liver disease.
• History of excess alcohol ingestion.
• Contraindications to liver biopsy.
• Decompensated liver disease.
• History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
• Recent initiation or change of anti-diabetic drugs.
• Use of colesevelam or other agents in the same class.
• 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.
• Positive test for anti-HIV.
• Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
• Pregnancy or inability to practice adequate contraception in women of childbearing potential.
• Evidence of hepatocellular carcinoma

Where it is running

• UCSD: Prevention Studies Clinic — La Jolla, California, United States
• UCSD: Medical Center- Hillcrest — San Diego, California, United States

Full record on ClinicalTrials.gov

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