Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544920
First received: February 28, 2012
Last updated: September 3, 2014
Last verified: September 2014

February 28, 2012
September 3, 2014
May 2012
June 2015   (final data collection date for primary outcome measure)
Overall Number of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 [ Time Frame: Baseline to Follow-up Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544920 on ClinicalTrials.gov Archive Site
Number of Participants Achieving SVR at Follow-up Week 24 Among Those Participants Who Had Achieved Rapid Virologic Response (RVR) [ Time Frame: Baseline to Follow-up Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Biological: peginterferon alfa-2a
    peginterferon alfa-2a vials 180 ug/week subcutaneous
    Other Names:
    • Pegasys™
    • SCH 054031
  • Drug: ribavirin
    ribavirin 1,000 mg/day (body weight <75 kg) or 1200 mg/day (body weight ≥75 kg) orally divided into two daily doses.
    Other Names:
    • Rebetol
    • 018908
  • Drug: boceprevir
    Four 200 mg capsules three times a day orally for a total daily dose of 2400 mg.
    Other Names:
    • SCH 503034
    • Victrelis
  • Active Comparator: PEG-IFN2a/RBV

    Participants receive an initial 4 week lead-in of PEG-IFN2a/RBV. A 1:1 ratio randomization occurs at Week 4:

    Participants randomized to the active comparator arm will receive open label PEG-IFN2a/RBV for a total of 24 weeks if HCV RNA is undetectable at Week 4.

    Participants who are HCV RNA detectable at Week 4 (non-RVR) will follow a response guided therapy recommendation. These participants will receive BOC/PEG-IFN2a/RBV regimen at Week 6 to allow for the HCV RNA laboratory process turnaround.

    Interventions:
    • Biological: peginterferon alfa-2a
    • Drug: ribavirin
    • Drug: boceprevir
  • Experimental: BOC/PEG-IFN2a/RBV
    Participants receive an initial 4-week lead-in of PEG-IFN2a/RBV. Participants randomized to the experimental arm at Week 4 will receive BOC/PEG-IFN2a/RBV for a total of 24 weeks if the HCV RNA is undetectable at Week 4 (RVR). Those participants who are HCV RNA detectable at Week 4 (Non-RVR) will follow a response guided therapy recommendation.
    Interventions:
    • Biological: peginterferon alfa-2a
    • Drug: ribavirin
    • Drug: boceprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
737
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01544920
P07755, 2011-001345-32, MK-3034-040, CTRI/2012/12/003200, PHRR131022-000133
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP