Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

Hepatitis C Clinical Trial

Official title:

A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704184
• Other study ID #: 7009-007
• Secondary ID: MK7009-0072007_6
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2008
• Est. completion date: April 14, 2010

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 14, 2010
• Est. primary completion date: December 12, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria:

• Subject has been previously treated for HCV

• Has Human Immunodeficiency Virus (HIV)

• Has Hepatitis B

• Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Comparator: Vaniprevir
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
• Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
• Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
• Comparator: placebo
Matching placebo to vaniprevir; duration of treatment: 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naïve patients with chronic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving RVR	Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.	Week 4
Primary	Number of Participants Experiencing an Adverse Event (AE)	The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.	Up to Day 42
Primary	Number of Participants Discontinuing From Study Therapy Due to AEs	An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.	Day 1 to Day 28
Secondary	Number of Participants With =2-log10 Decrease in HCV RNA	The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.	Baseline and Week 4
Secondary	Number of Participants With =3-log10 Decrease in HCV RNA	The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.	Baseline and Week 4
Secondary	Mean Log Change From Baseline in HCV RNA	The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.	Baseline and Week 4