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A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

9 juillet 2014 mis à jour par: Vertex Pharmaceuticals Incorporated

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

117

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

  • Allemagne
      • Berlin, Allemagne
      • Bonn, Allemagne
        • Universitatsklinikum Bonn
      • Cologne, Allemagne
        • University of Cologne
      • Dusseldorf, Allemagne, 40225
        • Uniklinik Duesseldorf
      • Frankfurt, Allemagne
      • Hannover, Allemagne
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary Medical Clinic
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
  • France
      • Creteil, France
        • Hospital Henri Mondor
      • Lyon, France
      • Nice, France
      • Paris, France
      • Pessac, France
      • Vandoeuvre, France
  • L'Autriche
      • Vienna, L'Autriche
  • Pays-Bas
      • Amsterdam, Pays-Bas
        • Academic Medical Center
      • Leiden, Pays-Bas
        • Leiden University Medical Center
      • Rotterdam, Pays-Bas
        • Erasmus MC Medical Center
  • Porto Rico
      • Santurce, Porto Rico
        • Fundacion de Investigation de Diego
  • Royaume-Uni
      • London, Royaume-Uni
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis
    • California
      • Los Angeles, California, États-Unis
      • San Diego, California, États-Unis
        • Kaiser Permanente Internal Medicine
      • San Francisco, California, États-Unis
    • Colorado
      • Denver, Colorado, États-Unis
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, États-Unis
        • South Denver Gastroenterology
    • Florida
      • Gainesville, Florida, États-Unis
        • University of Florida
      • Jacksonville, Florida, États-Unis
        • Borland-Groover Clinic
      • Jacksonville, Florida, États-Unis
        • Mayo Clinic Jacksonville
      • Miami, Florida, États-Unis
        • University of Miami Center for Liver Diseases
      • Sarasota, Florida, États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, États-Unis
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, États-Unis
    • Louisiana
      • Baton Rouge, Louisiana, États-Unis
        • Digestive and Liver Disease Clinic
    • Maine
      • Portland, Maine, États-Unis
        • Virology Treatment Center, Maine Medical Center
    • Maryland
      • Baltimore, Maryland, États-Unis
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, États-Unis
        • Beth Israel Deaconess Medical Center
      • Worcester, Massachusetts, États-Unis
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, États-Unis
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, États-Unis
        • St Louis University
    • Nebraska
      • Omaha, Nebraska, États-Unis
        • The Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, États-Unis
        • University of New Mexico
    • New York
      • Manhasset, New York, États-Unis
        • North Shore University Hospital
      • New York, New York, États-Unis
    • North Carolina
      • Durham, North Carolina, États-Unis
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, États-Unis
        • University of Cincinnati
      • Cleveland, Ohio, États-Unis
    • Pennsylvania
      • Hershey, Pennsylvania, États-Unis
        • Penn State Hershey Medical Center
      • Pittsburgh, Pennsylvania, États-Unis
        • University of Pittsburgh Medical Center
    • South Carolina
      • Columbia, South Carolina, États-Unis
        • Columbia Gastroenterology Associates, PA
    • Tennessee
      • Germantown, Tennessee, États-Unis
        • Memphis Gastroenterology Group
    • Texas
      • Dallas, Texas, États-Unis
        • Liver Institute at Methodist Dallas
      • Houston, Texas, États-Unis
      • San Antonio, Texas, États-Unis
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, États-Unis
      • Charlottesville, Virginia, États-Unis
        • University of Virginia Health Systems
      • Fairfax, Virginia, États-Unis
        • Metropolitan Research
      • Richmond, Virginia, États-Unis
        • McGuire DVAMC

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 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

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 parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (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 24 weeks.
Médicament: Ribavirine
Tablette
Médicament: Télaprévir
Tablette
Autres noms:
  • VX-950
Médicament: Pegylated interferon alfa 2a
Solution for Injection
Expérimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice 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.
Médicament: Ribavirine
Tablette
Médicament: Télaprévir
Tablette
Autres noms:
  • VX-950
Médicament: Pegylated interferon alfa 2a
Solution for Injection
Expérimental: Other
Subjects received telaprevir 750 mg tablet thrice daily 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Médicament: Ribavirine
Tablette
Médicament: Télaprévir
Tablette
Autres noms:
  • VX-950
Médicament: Pegylated interferon alfa 2a
Solution for Injection

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Délai: 24 weeks after the completion of treatment (up to Week 72)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Baseline through Week 48
AE: any adverse change from the subject'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 through Week 48

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Prior Relapsers With Undetectable HCV RNA
Délai: 24 weeks after the completion of treatment (up to Week 72)
Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
Délai: End of treatment (up to Week 48)
Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Délai: 48 weeks after completion of treatment (up to Week 96)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Délai: Baseline up to Week 72
Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Baseline up to Week 72

Collaborateurs et enquêteurs

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

Parrainer

Vertex Pharmaceuticals Incorporated

Collaborateurs

Tibotec, Inc

Les enquêteurs

  • Directeur d'études: Nathalie Adda, MD, 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 octobre 2007

Achèvement primaire (Réel)

1 février 2010

Achèvement de l'étude (Réel)

1 février 2010

Dates d'inscription aux études

Première soumission

25 septembre 2007

Première soumission répondant aux critères de contrôle qualité

25 septembre 2007

Première publication (Estimation)

26 septembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 août 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juillet 2014

Dernière vérification

1 juillet 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VX06-950-107

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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