Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

NCT ID: NCT00704405

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-27
• Study Completion Date: 2012-09-10

Brief Summary

The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).

Conditions

Hepatitis C, Chronic

Study Design

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

Study Groups

24-wk Vaniprevir 600 mg + Peg-IFN/RBV

Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.

Pegylated Interferon (Peg-IFN)

Intervention Type: DRUG

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Ribavirin (RBV)

Intervention Type: DRUG

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV

Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.

Pegylated Interferon (Peg-IFN)

Intervention Type: DRUG

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Ribavirin (RBV)

Intervention Type: DRUG

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

Placebo (PBO)

Intervention Type: DRUG

Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.

48-wk Vaniprevir 300 mg + Peg-IFN/RBV

Vaniprevir 300 mg (total daily dose, taken once daily \[q.d.\]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.

Pegylated Interferon (Peg-IFN)

Intervention Type: DRUG

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Ribavirin (RBV)

Intervention Type: DRUG

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

48-wk Vaniprevir 600 mg + Peg-IFN/RBV

Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.

Pegylated Interferon (Peg-IFN)

Intervention Type: DRUG

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Ribavirin (RBV)

Intervention Type: DRUG

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

48-wk PBO + Peg-IFN/RBV

PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Group Type: PLACEBO_COMPARATOR

Pegylated Interferon (Peg-IFN)

Intervention Type: DRUG

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Ribavirin (RBV)

Intervention Type: DRUG

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

Placebo (PBO)

Intervention Type: DRUG

Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.

Interventions

Vaniprevir

Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.

Intervention Type: DRUG

Pegylated Interferon (Peg-IFN)

Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks

Intervention Type: DRUG

Ribavirin (RBV)

Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg.

Intervention Type: DRUG

Placebo (PBO)

Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.

Intervention Type: DRUG

Other Intervention Names

MK-7009; PEGASYS™; COPEGUS™

Eligibility Criteria

Inclusion Criteria

• Has chronic HCV genotype 1 infection
• Is treatment-experienced
• For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion Criteria

• Has not tolerated previous course peg-IFN and RBV
• Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
• Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
• Consumes excessive amounts of alcohol
• Has a history of drug or alcohol abuse
• If female, participant is pregnant or breastfeeding
• Has been in a clinical trail with an investigational drug in the last 30 days
• Has used IFN/Peg-IFN and RBV in the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21.

Reference Type: RESULT

PMID: 23439259 (View on PubMed)

Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10.

Reference Type: RESULT

PMID: 24120953 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2007_659

Identifier Type: OTHER

Identifier Source: secondary_id

7009-009

Identifier Type: -

Identifier Source: org_study_id