A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

January 15, 2021 updated by: Merck Sharp & Dohme LLC

A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participant has participated in a prior vaniprevir clinical trial
  • Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

  • More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
  • Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
  • Participant received any investigational therapy for HCV after participating in the prior study

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
Drug: Vaniprevir 300 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
Drug: Pegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Names:
  • PEGASYS™
Drug: Ribavirin
Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks
Other Names:
  • COPEGUS™
Experimental: Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
Drug: Pegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Names:
  • PEGASYS™
Drug: Ribavirin
Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks
Other Names:
  • COPEGUS™
Drug: Vaniprevir 600 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced an Adverse Event
Time Frame: up to 72 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 72 weeks
Number of Participants Who Experienced a Serious Adverse Event
Time Frame: up to 72 weeks
Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
up to 72 weeks
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Time Frame: 48 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.
48 weeks
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
Time Frame: 72 weeks
SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
72 weeks

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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)

October 23, 2009

Primary Completion (Actual)

May 29, 2013

Study Completion (Actual)

May 29, 2013

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7009-028
  • 2009_615 (Other Identifier: Merck)
  • 2009-013053-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/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.

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