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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-23

Study Completion Date

2013-05-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

NCT00704184

Hepatitis C

COMPLETED PHASE2

Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

NCT00895882

Chronic Genotype 1 Hepatitis C Virus Infection

WITHDRAWN PHASE2

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)

NCT00704405

Hepatitis C, Chronic

COMPLETED PHASE2

Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

NCT01370642

Hepatitis C, Chronic

COMPLETED PHASE3

Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)

NCT01405560

Hepatitis C, Chronic

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Vaniprevir 300 mg b.i.d.

Intervention Type DRUG

Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks

Pegylated interferon

Intervention Type DRUG

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Ribavirin

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Vaniprevir 600 mg b.i.d.

Intervention Type DRUG

Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

Pegylated interferon

Intervention Type DRUG

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Ribavirin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaniprevir 600 mg b.i.d.

Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

Intervention Type 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

Intervention Type DRUG

Pegylated interferon

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PEGASYS™ COPEGUS™

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No