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
5 other identifiers
interventional
737
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedStudy Start
First participant enrolled
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2015
CompletedResults Posted
Study results publicly available
May 30, 2016
CompletedSeptember 11, 2018
August 1, 2018
3 years
February 28, 2012
April 22, 2016
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)
SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.
Up to Week 74
Secondary Outcomes (1)
Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24
Up to Week 48
Study Arms (2)
Arm 1: peg-IFN + RBV
ACTIVE COMPARATORParticipants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) \[Arm 1a\]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV \[Arm 1b\].
Arm 2: BOC + peg-IFN + RBV
EXPERIMENTALParticipants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) \[Arm 2a\]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV \[Arm 2b\].
Interventions
peg-IFN (180 ug) was taken once weekly via subcutaneous injection.
RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight \<75 kilograms \[kg\]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings.
Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 6, 2012
Study Start
May 30, 2012
Primary Completion
May 19, 2015
Study Completion
May 19, 2015
Last Updated
September 11, 2018
Results First Posted
May 30, 2016
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf