A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

September 10, 2018 updated by: Merck Sharp & Dohme LLC

A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection

The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has chronic genotype 1 Hepatitis C infection

Exclusion Criteria:

  • Has not tolerated previous course of peg-IFN and ribavirin
  • Has 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

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 200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Drug: Vaniprevir
Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
Other Names:
  • MK7009
Drug: Pegylated Interferon (peg-IFN)
Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
Drug: Ribavirin
Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
Experimental: Vaniprevir 600 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Drug: Vaniprevir
Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
Other Names:
  • MK7009
Drug: Pegylated Interferon (peg-IFN)
Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
Drug: Ribavirin
Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
Experimental: Vaniprevir 1200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Drug: Vaniprevir
Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
Other Names:
  • MK7009
Drug: Pegylated Interferon (peg-IFN)
Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
Drug: Ribavirin
Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
Placebo Comparator: Placebo + peg-IFN + ribavirin
Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Drug: Pegylated Interferon (peg-IFN)
Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
Drug: Ribavirin
Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
Drug: Comparator: Placebo
Placebo to vaniprevir oral capsule twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Rapid Viral Response
Time Frame: Week 4
Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
Time Frame: Baseline and Week 4
Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Baseline and Week 4
Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
Time Frame: Baseline and Week 4
Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Baseline and Week 4
Change From Baseline in HCV RNA in log10 at Week 4
Time Frame: Baseline and Week 4
Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Baseline and Week 4
Number of Participants Who Experienced at Least One Adverse Event
Time Frame: Up to 6 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Up to 6 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 6 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

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

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)

April 20, 2009

Primary Completion (Actual)

June 3, 2010

Study Completion (Actual)

February 23, 2012

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7009-016
  • 2009_576

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

  1. CSR Synopsis

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

Clinical Trials on Vaniprevir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe