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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 luglio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

117

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Ribavirina
Tavoletta
Droga: Telaprevir
Tavoletta
Altri nomi:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection
Sperimentale: 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.
Droga: Ribavirina
Tavoletta
Droga: Telaprevir
Tavoletta
Altri nomi:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection
Sperimentale: 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.
Droga: Ribavirina
Tavoletta
Droga: Telaprevir
Tavoletta
Altri nomi:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Prior Relapsers With Undetectable HCV RNA
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaboratori

Tibotec, Inc

Investigatori

  • Direttore dello studio: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2007

Completamento primario (Effettivo)

1 febbraio 2010

Completamento dello studio (Effettivo)

1 febbraio 2010

Date di iscrizione allo studio

Primo inviato

25 settembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

25 settembre 2007

Primo Inserito (Stima)

26 settembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 agosto 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2014

Ultimo verificato

1 luglio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VX06-950-107

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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