Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2014 |
Start Date: | May 2012 |
End Date: | February 2016 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects
The primary purpose of this study is to compare the efficacy of two boceprevir
(BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic
hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.
The regimens differ in the treatment for participants who achieve HCV ribonucleic acid (RNA)
undetectability at the end of the peginterferon alfa-2a (PEG-IFN2a) plus ribavirin (RBV) 4
week lead-in. Participants receive either PEG-IFN2a plus RBV alone or BOC plus PEG-IFN2a
plus RBV.
(BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic
hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.
The regimens differ in the treatment for participants who achieve HCV ribonucleic acid (RNA)
undetectability at the end of the peginterferon alfa-2a (PEG-IFN2a) plus ribavirin (RBV) 4
week lead-in. Participants receive either PEG-IFN2a plus RBV alone or BOC plus PEG-IFN2a
plus RBV.
Inclusion Criteria:
- Is ≥ 40 kg and ≤ 125 kg.
- Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL
- Has IL-28B CC allele gene
- Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma
(non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).
Exclusion Criteria:
- Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus
(Hepatitis B surface antigen [HBsAg] or HIV positive).
- Previously treated with an interferon and ribavirin regimen or HCV direct acting
antiviral regimen.
- Treatment for hepatitis C with any investigational medication, or prior treatments
with herbal remedies with known hepatotoxicity
- Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly
dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated
plasma concentrations could be associated with serious and/or life-threatening events
- Participation in any other clinical trial within 30 days of the screening visit in
this trial or intention to participate in another clinical trial during participation
in this trial.
- Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
- Is diabetic and/or hypertensive with significant retinopathy
- Has any known medical condition that could interfere with the participation in and
completion of the trial including immunologically-mediated disease, chronic pulmonary
disease, or current or history of any clinically significant cardiac
abnormalities/dysfunction.
- Evidence of active or suspected malignancy, or a history of malignancy, within the
last 5 years
- Hemoglobin <12 g/dL for females and <13 g/dL for males
- Neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of African descent
- Platelets <150,000/mm^3
- Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference
range.
We found this trial at
26
sites
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