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

NCT00943761 | Completed Phase 2 Results

• 3 other identifiers: 7009-0282009_6152009-013053-15
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Vaniprevir 300 mg b.i.d. + peg-IFN + RBV

EXPERIMENTAL

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.

Drug: Vaniprevir 300 mg b.i.d.; Drug: Pegylated interferon; Drug: Ribavirin

Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

EXPERIMENTAL

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.

Drug: Vaniprevir 600 mg b.i.d.; Drug: Pegylated interferon; Drug: Ribavirin

Interventions

Vaniprevir 600 mg b.i.d. DRUG

Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

Vaniprevir 300 mg b.i.d. DRUG

Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks

Vaniprevir 300 mg b.i.d. + peg-IFN + RBV

Pegylated interferon DRUG

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Also known as: PEGASYS™

Vaniprevir 300 mg b.i.d. + peg-IFN + RBV; Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

Ribavirin DRUG

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

Also known as: COPEGUS™

Vaniprevir 300 mg b.i.d. + peg-IFN + RBV; Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has participated in a prior vaniprevir clinical trial
• Participant agrees to use acceptable birth control method during treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

vaniprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: October 23, 2009
• Primary Completion: May 29, 2013
• Study Completion: May 29, 2013
• Last Updated: February 8, 2021
• Results First Posted: September 29, 2014

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share