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
• Trial end date: 2015-05-19
• Target enrollment: 0
• Participant gender: All

Summary

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 undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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.