A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM5)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00943761

First received: July 21, 2009

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 21, 2009
Last Updated Date	December 13, 2012
Start Date ^ICMJE	June 2010
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2011)	Number of participants with adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ] Number of participants with serious adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ] Number of participants achieving sustained viral response 24 weeks after the end of treatment (SVR24) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: July 21, 2009)	Proportion of patients achieving Sustained Viral Response 24 weeks after the end of treatment (SVR24) in patients previously treated with placebo + peg-IFN + RBV in a MK7009 clinical trial [ Time Frame: 24 Weeks after the end of treatment ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00943761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM5)
Official Title ^ICMJE	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
Brief Summary	This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon and ribavirin to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis C, Chronic
Intervention ^ICMJE	Drug: Vaniprevir (600 mg b.i.d.) Capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks Drug: Vaniprevir (300 mg b.i.d.) Capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks Drug: Pegylated interferon (Peg-IFN) Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks Other Name: PEGASYS™ Drug: Ribavirin (RBV) Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks Other Name: COPEGUS™
Study Arm (s)	Experimental: Vaniprevir (600 mg b.i.d.) + peg-IFN + RBV Interventions: Drug: Vaniprevir (600 mg b.i.d.) Drug: Pegylated interferon (Peg-IFN) Drug: Ribavirin (RBV) Experimental: Vaniprevir (300 mg b.i.d.) + peg-IFN + RBV Interventions: Drug: Vaniprevir (300 mg b.i.d.) Drug: Pegylated interferon (Peg-IFN) Drug: Ribavirin (RBV)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	May 2013
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00943761
Other Study ID Numbers ^ICMJE	7009-028, 2009_615
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top