Trial record 1 of 1 for:    Merck p07755
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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: May 19, 2014
Last verified: May 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 ]

Enrollment: 737
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 19, 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 July 23, 2014