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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Vaniprevir 600 mg b.i.d.
* Drug: Vaniprevir 300 mg b.i.d.
* Drug: Pegylated interferon
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention 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<br>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.<br>* Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks<br>Drug: Pegylated interferon<br>* Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks<br>* Other names: PEGASYS™;Drug: Ribavirin<br>* 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<br>* Other names: COPEGUS™;|
| Experimental: Vaniprevir 600 mg b.i.d. + peg-IFN + RBV<br>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: Vaniprevir 600 mg b.i.d.<br>* Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks<br>Drug: Pegylated interferon<br>* Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks<br>* Other names: PEGASYS™;Drug: Ribavirin<br>* 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<br>* Other names: COPEGUS™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C