Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
3 other identifiers
interventional
95
0 countries
N/A
Brief Summary
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedStudy Start
First participant enrolled
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2010
CompletedResults Posted
Study results publicly available
October 1, 2014
CompletedOctober 9, 2018
September 1, 2018
5 months
June 23, 2008
September 26, 2014
September 10, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving RVR
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Week 4
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Up to Day 42
Number of Participants Discontinuing From Study Therapy Due to AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
Day 1 to Day 28
Secondary Outcomes (3)
Number of Participants With ≥2-log10 Decrease in HCV RNA
Baseline and Week 4
Number of Participants With ≥3-log10 Decrease in HCV RNA
Baseline and Week 4
Mean Log Change From Baseline in HCV RNA
Baseline and Week 4
Study Arms (5)
Placebo + Peg-IFN/Ribavirin
PLACEBO COMPARATORParticipants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
EXPERIMENTALParticipants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
EXPERIMENTALParticipants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
EXPERIMENTALParticipants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
EXPERIMENTALParticipants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Interventions
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Matching placebo to vaniprevir; duration of treatment: 28 days
Eligibility Criteria
You may qualify if:
- Patient has chronic Genotype 1 Hepatitis C infection
You may not qualify if:
- Subject has been previously treated for HCV
- Has Human Immunodeficiency Virus (HIV)
- Has Hepatitis B
- Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
PMID: 22473713RESULTLawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
PMID: 23747481DERIVED
MeSH Terms
Conditions
Interventions
Condition 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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 24, 2008
Study Start
July 25, 2008
Primary Completion
December 12, 2008
Study Completion
April 14, 2010
Last Updated
October 9, 2018
Results First Posted
October 1, 2014
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf