Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00699036
• Other study ID #: C.2007.066
• Status: Recruiting
• Phase: Phase 2
• First received: June 16, 2008
• Last updated: June 18, 2009
• Start date: April 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2009
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients between 18-70 years old

2. Negative urine pregnancy test in females

3. History of elevated liver associated enzymes (ALT > 40)

4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

1. ALT greater than three times normal

2. NYHA class 3 or 4 heart failure

3. Any congestive heart failure patient on insulin

4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment

5. Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male

6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis

7. Serum creatinine on initial screening of greater than 1.4

8. Known hypersensitivity to rosiglitazone, metformin, or losartan

9. Known history of diabetic ketoacidosis

10. Female that is breastfeeding

11. Insulin dependent diabetic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• avandia
4 mg twice daily
• metformin
500 mg twice daily for 48 weeks
• losartan
losartan 50 mg once daily

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver biopsy histologic improvement		end of study	No
Secondary	serum transaminases		throughout study (ongoing)	Yes