Status:
TERMINATED
Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients
Lead Sponsor:
Hossam Kandil
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 vir...
Detailed Description
This study is designed to be an interventional, prospective, randomized, double-blinded case-control clinical trial. Procedures will be done in the Center for Liver Diseases, 9'Th floor of Kaufmann me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00871845
Start Date
September 1 2008
End Date
August 1 2011
Last Update
November 5 2018
Active Locations (1)
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1
Center for Liver Diseases, UPMC.
Pittsburgh, Pennsylvania, United States, 15213