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: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Biological: peginterferon alfa-2a
Drug: ribavirin
Drug: boceprevir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1250
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544920

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544920     History of Changes
Other Study ID Numbers: P07755, 2011-001345-32, MK-3034-040, CTRI/2012/12/003200, PHRR131022-000133
Study First Received: February 28, 2012
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014