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

Merck Sharp & Dohme LLC45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

Vaniprevir 600 mg b.i.d.DRUG

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

Vaniprevir 300 mg b.i.d.DRUG

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

Pegylated interferonDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event

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.

Time frame: up to 72 weeks

Number of Participants Who Experienced a Serious Adverse Event

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.

Time frame: up to 72 weeks

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

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.

Time frame: 48 weeks

Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)

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.

Time frame: 72 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.