A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vaniprevir 600 mg b.i.d.
Vaniprevir 300 mg b.i.d.
Pegylated interferon
Ribavirin
Sponsored by

About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00943761
First Posted
July 21, 2009
Last Updated
January 15, 2021
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00943761
Brief Title
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2009 (Actual)
Primary Completion Date
May 29, 2013 (Actual)
Study Completion Date
May 29, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vaniprevir 600 mg b.i.d.
Intervention Description
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Vaniprevir 300 mg b.i.d.
Intervention Description
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon
Other Intervention Name(s)
PEGASYS™
Intervention Description
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
COPEGUS™
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced an Adverse Event
Description
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
Title
Number of Participants Who Experienced a Serious Adverse Event
Description
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
Title
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Description
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
Title
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=7009-028&kw=7009-028&tab=access
Learn more about this trial
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
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