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VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

14 maggio 2014 aggiornato da: Janssen Infectious Diseases BVBA

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

744

Fase

  • Fase 3

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

  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Clayton, Australia
      • Darlinghurst, Australia
      • Fitzroy, Australia
      • Greenslopes, Australia
      • Melbourne, Australia
      • Perth, Australia
  • Austria
      • Graz N/A, Austria
      • Linz, Austria
      • Wien, Austria
  • Belgio
      • Antwerpen, Belgio
      • Brussels, Belgio
      • Genk, Belgio
      • Gent, Belgio
      • Leuven, Belgio
      • Liege, Belgio
  • Brasile
      • Campinas, Brasile
      • Salvador, Brasile
      • Santo Andre, Brasile
      • Sao Paulo, Brasile
      • São Paulo, Brasile
  • Francia
      • Clichy, Francia
      • Creteil, Francia
      • Grenoble, Francia
      • Lille, Francia
      • Lyon, Francia
      • Paris, Francia
      • Pessac, Francia
      • Vandoeuvre Les Nancy, Francia
      • Villejuif Cedex, Francia
  • Germania
      • Berlin, Germania
      • Bochum, Germania
      • Essen, Germania
      • Frankfurt, Germania
      • Hamburg, Germania
      • Kiel, Germania
      • Mainz, Germania
      • Regensburg, Germania
  • Irlanda
      • Dublin, Irlanda
      • Dublin 9, Irlanda
  • Messico
      • Mex Ctity, Messico
      • Mexico, Messico
      • Monterrey, Messico
  • Polonia
      • Bialystok, Polonia
      • Bydgoszcz, Polonia
      • Czeladz, Polonia
      • Kielce, Polonia
      • Krakow, Polonia
      • Warszawa, Polonia
  • Regno Unito
      • Birmingham, Regno Unito
      • Edinburgh, Regno Unito
      • Glasgow, Regno Unito
      • London, Regno Unito
      • Manchester, Regno Unito
  • Spagna
      • Barcelona, Spagna
      • Barcelona N/A, Spagna
      • Madrid, Spagna
      • Malaga N/A, Spagna
      • Santander N/A, Spagna
      • Sevilla N/A, Spagna
      • Valencia, Spagna
  • Stati Uniti
    • California
      • La Jolla, California, Stati Uniti
      • Los Angeles, California, Stati Uniti
      • San Diego, California, Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti
    • Florida
      • Bradenton, Florida, Stati Uniti
      • Jacksonville, Florida, Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti
      • Marietta, Georgia, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
      • Downers Grove, Illinois, Stati Uniti
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti
    • Maryland
      • Lutherville, Maryland, Stati Uniti
    • Missouri
      • Kansas City, Missouri, Stati Uniti
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti
    • New Jersey
      • Egg Harbor Twp, New Jersey, Stati Uniti
    • New Mexico
      • Santa Fe, New Mexico, Stati Uniti
    • New York
      • New York, New York, Stati Uniti
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti
      • Durham, North Carolina, Stati Uniti
      • Statesville, North Carolina, Stati Uniti
      • Winston Salem, North Carolina, Stati Uniti
    • Ohio
      • Cincinnati, Ohio, Stati Uniti
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti
      • Hershey, Pennsylvania, Stati Uniti
      • Philadelphia, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
      • Columbia, South Carolina, Stati Uniti
    • Texas
      • Arlington, Texas, Stati Uniti
      • Dallas, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
      • San Antonio, Texas, Stati Uniti
    • Virginia
      • Falls Church, Virginia, Stati Uniti
      • Norfolk, Virginia, Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti
  • Svezia
      • Göteborg, Svezia
      • Malmö, Svezia
      • Stockholm, Svezia

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:

  • Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
  • Patients should not have had any previous treatment for hepatitis C
  • Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
  • Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

  • Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
  • Patient has a pre-existing psychiatric condition
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Droga: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Droga: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Sperimentale: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Droga: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Droga: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Lasso di tempo: End of trial, 12 weeks after last planned dose
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
End of trial, 12 weeks after last planned dose

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Lasso di tempo: End of trial, 24 weeks after last planned dose
The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
End of trial, 24 weeks after last planned dose
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Lasso di tempo: End of trial, 72 weeks after the start of study medication
The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
End of trial, 72 weeks after the start of study medication
Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Lasso di tempo: Baseline, Week 4 and Week 4+12.
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
Baseline, Week 4 and Week 4+12.
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Lasso di tempo: Week 4, 12, 24, 32, 40
The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
Week 4, 12, 24, 32, 40
Percentage of Participants Who Relapsed During Follow-up Period
Lasso di tempo: During Follow-Up (24 weeks after the last dose of study drug)
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
During Follow-Up (24 weeks after the last dose of study drug)
Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Lasso di tempo: End of trial, 12 weeks after the last planned dose
The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
End of trial, 12 weeks after the last planned dose

Collaboratori e investigatori

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

Sponsor

Janssen Infectious Diseases BVBA

Collaboratori

Vertex Pharmaceuticals Incorporated

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 dicembre 2010

Completamento primario (Effettivo)

1 agosto 2012

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

28 ottobre 2010

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2010

Primo Inserito (Stima)

16 novembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 giugno 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR013711
  • OPTIMIZE-HCV (Altro identificatore: Janssen Infectious Diseases BVBA)
  • VX-950-C211 (Altro identificatore: Janssen Infectious Diseases BVBA)
  • 2010-021628-84 (Numero EudraCT)

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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