Overview

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.