Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

NCT ID: NCT01370642

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-27
• Study Completion Date: 2014-03-17

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaniprevir 12 Week Arm

Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.

Group Type: EXPERIMENTAL

vaniprevir

Intervention Type: DRUG

Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks

Placebo to vaniprevir

Intervention Type: DRUG

Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks

Peg-IFN

Intervention Type: BIOLOGICAL

Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks

ribavirin

Intervention Type: DRUG

Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Vaniprevir 24 Week Arm

Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.

Group Type: EXPERIMENTAL

vaniprevir

Intervention Type: DRUG

Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks

Peg-IFN

Intervention Type: BIOLOGICAL

Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks

ribavirin

Intervention Type: DRUG

Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Control Arm

Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.

Group Type: ACTIVE_COMPARATOR

Placebo to vaniprevir

Intervention Type: DRUG

Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks

Peg-IFN

Intervention Type: BIOLOGICAL

Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks

ribavirin

Intervention Type: DRUG

Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Interventions

vaniprevir

Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks

Intervention Type: DRUG

Placebo to vaniprevir

Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks

Intervention Type: DRUG

Peg-IFN

Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks

Intervention Type: BIOLOGICAL

ribavirin

Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Intervention Type: DRUG

Other Intervention Names

MK-7009; PegIntron; REBETOL®

Eligibility Criteria

Inclusion Criteria

• Japanese participant diagnosed with compensated CHC GT 1
• Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
• IFN treatment naive
• No evidence of cirrhosis

Exclusion Criteria

• Co-infection with human immunodeficiency virus (HIV)
• Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
• Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
• Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hayashi N, Nakamuta M, Takehara T, Kumada H, Takase A, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study. J Gastroenterol. 2016 Apr;51(4):390-403. doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.

Reference Type: RESULT

PMID: 26403160 (View on PubMed)

Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.

Reference Type: DERIVED

PMID: 26947564 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

7009-043

Identifier Type: -

Identifier Source: org_study_id