Clinical trial NCT01544920: Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
Official title: A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)
timeFrame: Up to Week 74
Secondary outcomes:
measure: Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24
timeFrame: Up to Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: