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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943761
• Other study ID #: 7009-028
• Secondary ID: 2009_6152009-013
• Status: Completed
• Phase: Phase 2
• Start date: October 23, 2009
• Est. completion date: May 29, 2013

Study information

• Verified date: January 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 29, 2013
• Est. primary completion date: May 29, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Vaniprevir 600 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
• Vaniprevir 300 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
• Pegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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