Clinical trial NCT01405937: Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
Official title: A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).


Eligibility criteria: Inclusion Criteria:

* Japanese participant diagnosed with compensated CHC GT 1
* Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
* Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
* No evidence of cirrhosis

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV)
* Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
* Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
* Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
timeFrame: 24 weeks after 24 weeks of study therapy (up to 48 weeks)
measure: Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
timeFrame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
Secondary outcomes:
measure: Percentage of Participants Achieving SVR12
timeFrame: 12 weeks after 24 weeks of study therapy (up to 36 weeks)
measure: Percentage of Participants Achieving Rapid Virologic Response (RVR)
timeFrame: At Week 4
measure: Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
timeFrame: At Week 12
measure: Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
timeFrame: At Week 24
measure: Mean Change From Baseline in HCV RNA (Log 10)
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kumada H, Mochida S, Suzuki F, Chayama K, Karino Y, Nakamura K, Fujimoto G, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 (GT1b) infection: Phase 3 studies. J Gastroenterol Hepatol. 2016 Oct;31(10):1674-1683. doi: 10.1111/jgh.13328.
citation: Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.