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Completed

NCT Number: NCT01370642

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

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vaniprevir

Drug

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

Other names: MK-7009

Placebo to vaniprevir

Drug

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

Peg-IFN

Biological

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

Other names: PegIntron

Ribavirin

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

Other names: REBETOL®

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)

    Time frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)

    SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.

  2. Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study

    Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

    An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).

  3. Percentage of Participants Who Discontinued Study Drug Due to an AE

    Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

    An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.

Secondary outcomes

  1. Percentage of Participants Achieving SVR12

    Time frame: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)

    SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.

  2. Percentage of Participants Achieving Rapid Virologic Response (RVR)

    Time frame: At Week 4

    RVR was defined as having an undetectable HCV RNA level at Week 4.

  3. Percentage of Participants Achieving Complete Early Virologic Response (cEVR)

    Time frame: At Week 12

    cEVR was defined as having an undetectable HCV RNA level at Week 12.

  4. Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)

    Time frame: At Week 24 or 48

    Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.

  5. Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

    HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered "undetectable".

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 10, 2011
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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