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An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

1 juin 2015 mis à jour par: Vertex Pharmaceuticals Incorporated

A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

61

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis
        • Alabama
    • Arizona
      • Phoenix, Arizona, États-Unis
        • Arizona
    • California
      • Los Angeles, California, États-Unis
        • California
    • Colorado
      • Denver, Colorado, États-Unis
        • Colorado
    • Florida
      • Bradenton, Florida, États-Unis
        • Florida
      • Miami, Florida, États-Unis
        • Florida
    • Illinois
      • Evanston, Illinois, États-Unis
        • Illinios
    • Indiana
      • Indianapolis, Indiana, États-Unis
        • Indiana
    • Massachusetts
      • Burlington, Massachusetts, États-Unis
        • Massachusetts
    • Michigan
      • Ann Arbor, Michigan, États-Unis
        • Michigan
      • Detroit, Michigan, États-Unis
        • Michigan
    • Missouri
      • St Louis, Missouri, États-Unis
        • Missouri
    • Nebraska
      • Omaha, Nebraska, États-Unis
        • Nebraska
    • New York
      • New York, New York, États-Unis
        • New York
      • Rochester, New York, États-Unis
        • New York
    • North Carolina
      • Charlotte, North Carolina, États-Unis
        • North Carolina
    • Ohio
      • Cleveland, Ohio, États-Unis
        • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis
        • Pennsylvania
    • Texas
      • Dallas, Texas, États-Unis
        • Texas
      • Houston, Texas, États-Unis
        • Texas

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Male and female participants between the ages of 18 and 65 years
  • History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
  • Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
  • Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response

Exclusion Criteria:

  • Documented cirrhosis after liver transplantation
  • Ascites or hepatic encephalopathy within 6 months before Screening
  • Retransplantation for recurrent hepatitis C
  • Treatment for hepatitis C post liver transplantation
  • History within the past 3 months of: rejection within 3 months or greater than (>) 1 rejection within 12 months
  • Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 milligram per day) is permitted
  • History within 3 months of any bacterial infection requiring >1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
  • History of post transplant lymphoproliferative disease
  • Acceptable laboratory values at Screening as specified in the protocol
  • Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
  • History of hepatocellular carcinoma with high risk of recurrence
  • Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
  • Autoimmune-mediated disease
  • History of acute pancreatitis within 5 years before the Screening visit
  • Prior treatment with an hepatitis C virus (HCV) protease inhibitor

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: T/PR + Immunosuppressant Regimen (Tacrolimus)
Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Médicament: Ribavirine
Tablette
Autres noms:
  • Copegus®, RBV
Médicament: Télaprévir
Tablette
Autres noms:
  • VX-950
Médicament: Interféron pégylé Alfa-2a
Injection sous-cutanée
Autres noms:
  • Pegasys®, Peg-IFN-alfa-2a
Médicament: Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Expérimental: T/PR + Immunosuppressant Regimen (Cyclosporine)
Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Médicament: Ribavirine
Tablette
Autres noms:
  • Copegus®, RBV
Médicament: Télaprévir
Tablette
Autres noms:
  • VX-950
Médicament: Interféron pégylé Alfa-2a
Injection sous-cutanée
Autres noms:
  • Pegasys®, Peg-IFN-alfa-2a
Médicament: Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Délai: 12 weeks after last planned dose of study drug (up to Week 60)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
12 weeks after last planned dose of study drug (up to Week 60)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
Délai: 24 weeks after last planned dose of study drug (up to Week 72)
SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
24 weeks after last planned dose of study drug (up to Week 72)
Percentage of Participants With Rapid Viral Response (RVR)
Délai: Week 4
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
Week 4
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Délai: Week 4 and Week 12
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.
Week 4 and Week 12
Percentage of Participants With On-Treatment Virologic Failure
Délai: Baseline up to Week 48
On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.
Baseline up to Week 48
Percentage of Participants With Viral Relapse
Délai: 48 weeks
48 weeks
Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)
Délai: 48 weeks
48 weeks
Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications
Délai: 48 weeks
48 weeks
Percentage of Participants With Biopsy Confirmed and Treated Rejection
Délai: 48 weeks
48 weeks
Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage
Délai: 48 weeks
48 weeks
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Délai: 48 weeks
48 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Baseline up to Week 52
Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline up to Week 52

Autres mesures de résultats

Mesure des résultats
Délai
Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Délai: 4 weeks after last planned dose of study drug (up to Week 52)
4 weeks after last planned dose of study drug (up to Week 52)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vertex Pharmaceuticals Incorporated

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2012

Achèvement primaire (Réel)

1 avril 2014

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

3 novembre 2011

Première soumission répondant aux critères de contrôle qualité

3 novembre 2011

Première publication (Estimation)

8 novembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

18 juin 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2015

Dernière vérification

1 juin 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VX11-950-117

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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