Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:4/21/2016
Start Date:September 2011
End Date:July 2015

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The purpose of this observational study is to compare two approved treatment regimen(s)
containing boceprevir and telaprevir, as part of standard of care for the treatment of
hepatitis C.

The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV)
protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment
regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data
will be obtained from medical records of consenting patients.

Inclusion Criteria:

- Age - 18-64 years

- HCV genotype 1

- HCV RNA >100,000

- Liver biopsy within 5 years before enrollment

- Absolute neutrophil count of at least 1200 per cubic millimeter

- Platelet count of at least 90,000 per cubic millimeter

- Hemoglobin level of at least 12 g per deciliter

- Signed informed consent and Health Insurance Portability and Accountability Act
(HIPAA) forms

Exclusion Criteria:

- HCV genotypes other than genotype 1

- Immunocompromised conditions including HIV, transplant or immunosuppressive drugs

- Decompensated liver disease or hepatocellular carcinoma

- Any other types of active cancer

- Active autoimmune disorders

- Major psychiatric disorders

- Active drug or alcohol use

- Pregnancy or lactation

- Patients with allergy to any of the drugs used in this study

- Drugs that may interact with boceprevir or telaprevir as listed in the package insert
We found this trial at
1
site
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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mi
from
Springfield, IL
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