Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
2 other identifiers
interventional
285
0 countries
N/A
Brief Summary
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Typical duration for phase_2
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
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedStudy Start
First participant enrolled
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2012
CompletedResults Posted
Study results publicly available
September 29, 2014
CompletedOctober 9, 2018
September 1, 2018
3 years
June 23, 2008
September 26, 2014
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.
Up to 72 weeks
Number of Participants Experiencing an Adverse Event (AE)
The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Up to 73 weeks
Number of Participants Discontinuing From Study Treatment Due to AEs
The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.
Up to 48 weeks
Secondary Outcomes (3)
Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.
72 weeks
Percentage of Participants Achieving cEVR
Up to Week 60
Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.
Week 48
Study Arms (5)
24-wk Vaniprevir 600 mg + Peg-IFN/RBV
EXPERIMENTALVaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV
EXPERIMENTALVaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
48-wk Vaniprevir 300 mg + Peg-IFN/RBV
EXPERIMENTALVaniprevir 300 mg (total daily dose, taken once daily \[q.d.\]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
48-wk Vaniprevir 600 mg + Peg-IFN/RBV
EXPERIMENTALVaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
48-wk PBO + Peg-IFN/RBV
PLACEBO COMPARATORPBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Interventions
Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.
Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.
Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.
Eligibility Criteria
You may qualify if:
- Has chronic HCV genotype 1 infection
- Is treatment-experienced
- For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
You may not qualify if:
- Has not tolerated previous course peg-IFN and RBV
- Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
- Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
- Consumes excessive amounts of alcohol
- Has a history of drug or alcohol abuse
- If female, participant is pregnant or breastfeeding
- Has been in a clinical trail with an investigational drug in the last 30 days
- Has used IFN/Peg-IFN and RBV in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21.
PMID: 23439259RESULTRodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10.
PMID: 24120953RESULT
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 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
March 27, 2009
Primary Completion
March 26, 2012
Study Completion
September 10, 2012
Last Updated
October 9, 2018
Results First Posted
September 29, 2014
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf