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

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ClinicalTrials.gov Identifier: NCT00943761
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : September 29, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Vaniprevir 600 mg b.i.d. Drug: Vaniprevir 300 mg b.i.d. Drug: Pegylated interferon Drug: Ribavirin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2009
Actual Primary Completion Date : May 29, 2013
Actual Study Completion Date : May 29, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
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.
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks

Drug: Pegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Name: PEGASYS™

Drug: 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
Other Name: COPEGUS™

Experimental: Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
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.
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

Drug: Pegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Name: PEGASYS™

Drug: 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
Other Name: COPEGUS™




Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: up to 72 weeks ]
    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.

  2. Number of Participants Who Experienced a Serious Adverse Event [ Time Frame: up to 72 weeks ]
    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.

  3. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event [ Time Frame: 48 weeks ]
    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.

  4. Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) [ Time Frame: 72 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943761


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943761     History of Changes
Other Study ID Numbers: 7009-028
2009_615 ( Other Identifier: Merck )
2009-013053-15 ( EudraCT Number )
First Posted: July 22, 2009    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: October 9, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Keywords provided by Merck Sharp & Dohme Corp.:
hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action