Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 222
• Participant gender: Both

Summary

The purpose of this study is to determine whether obese people do not respond to hepatitis C treatment as well as lean people. This research studies whether obese people will show higher sustained virologic response rate if they lose weight by Orlistat use and dietary and lifestyle modification.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Orlistat
• Last Updated: 2009-03-26

Criteria

Inclusion Criteria:

• 18 years or older

• positive diagnosis of hepatitis C, by Polymerase Chain Reaction (PCR

• scheduled to start treatment of hepatitis C by peg interferon and ribavirin

• agreeing to give a written consent to participate in this study.

Exclusion Criteria:

• patients under 18 years of age

• refusal to give a consent to participate in the study

• history of recreational drug or alcohol use in the preceding 6 months

• pregnancy by hCG pregnancy testing which will be done prior to and monthly during the 12 month hepatitis C therapy and for 6 months following the end of treatment

• plan for pregnancy during the study period

• failure to adhere to contraceptive methods

• HIV disease

• evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC), evidence of decompensated liver disease or presence of other liver diseases such as hepatitis B, hemochromatosis, autoimmune hepatitis and Wilson disease

• Patients will be removed from the study if they develop severe side effects to IFN (e.g marked depression, autoimmune reactions like thyroiditis, aplastic anemia..), severe side effects to ribavirin (e.g. marked hemolysis) or intolerance of Orlistat/placebo (e.g. allergic reaction, diarrhea, flatulence..) and withdrawal of the consent.