Status:
WITHDRAWN
Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism
Lead Sponsor:
University of Vermont
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with...
Detailed Description
Chronic infection with the hepatitis C virus (HCV), which affects 1-2% of adults in the United States, is a major risk factor for liver failure due to cirrhosis and/or hepatocellular carcinoma (Davis ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Serum Hepatitis C RNA \> 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B polymorphism
Exclusion
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST \> 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- Contraindications to PR-based treatment:
- uncontrolled psychiatric illness
- active substance dependency
- Known autoimmune disorder
- Untreated thyroid disease
- Uncontrolled seizure disorder
- Pregnancy, lactation or inability to maintain contraception
- Chronic kidney disease w/ estimated GFR\< 60
- ANC\<1.5/nl, Hb\<12g/dl, or platelets\<75/nl
- Clinical or biochemical evidence of decompensated liver disease including:
- History of encephalopathy, ascites, or variceal bleeding OR
- Bilirubin \> 3g/dl or INR \> 1.5
- Life threatening disorder with expected median survival less than 5 years
- Inability to comply with drug regimens or testing schedule required for study
- Lack of insurance coverage for any of the study medications
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01415141
Start Date
July 1 2011
End Date
July 1 2011
Last Update
May 9 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University School of Medicine
Atlanta, Georgia, United States, 30030
2
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401