- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370642
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
September 21, 2018 updated by: Merck Sharp & Dohme LLC
A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1.
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 arms is superior to the percentage of participants achieving SVR24 in the control arm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
294
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- IFN treatment naive
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
|
Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
Other Names:
Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
Other Names:
Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
Other Names:
|
Experimental: Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
|
Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
Other Names:
Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
Other Names:
Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
Other Names:
|
Active Comparator: Control Arm
Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
|
Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
Other Names:
Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
Time Frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
|
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.
|
24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
|
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study
Time Frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
|
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.
For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance.
Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).
|
From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time Frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
|
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.
|
From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving SVR12
Time Frame: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)
|
SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.
|
12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)
|
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Time Frame: At Week 4
|
RVR was defined as having an undetectable HCV RNA level at Week 4.
|
At Week 4
|
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
Time Frame: At Week 12
|
cEVR was defined as having an undetectable HCV RNA level at Week 12.
|
At Week 12
|
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
Time Frame: At Week 24 or 48
|
Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.
|
At Week 24 or 48
|
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24
|
HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values.
HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL.
HCV RNA levels below the LoD were considered "undetectable".
|
Baseline, Week 2, Week 4, Week 8, Week 12, Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hayashi N, Nakamuta M, Takehara T, Kumada H, Takase A, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study. J Gastroenterol. 2016 Apr;51(4):390-403. doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2011
Primary Completion (Actual)
July 31, 2013
Study Completion (Actual)
March 17, 2014
Study Registration Dates
First Submitted
June 8, 2011
First Submitted That Met QC Criteria
June 9, 2011
First Posted (Estimate)
June 10, 2011
Study Record Updates
Last Update Posted (Actual)
October 18, 2018
Last Update Submitted That Met QC Criteria
September 21, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- 7009-043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C, Chronic
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Hospices Civils de LyonCompleted
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States, Puerto Rico
Clinical Trials on vaniprevir
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCTerminatedChronic Hepatitis C Infection
-
Merck Sharp & Dohme LLCWithdrawnChronic Genotype 1 Hepatitis C Virus Infection
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted