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A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

15 luglio 2013 aggiornato da: Hoffmann-La Roche

A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

235

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
      • Darlinghurst, Australia, 2010
      • Fremantle, Australia, 6160
      • Melbourne, Australia, 3186
      • Nedlands, Australia, 6009
      • Sydney, Australia, 2139
  • Austria
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4010
      • Oberndorf, Austria, 5110
      • Wien, Austria, 1160
      • Wien, Austria, 1090
  • Belgio
      • Antwerpen, Belgio, 2650
      • Bruxelles, Belgio, 1020
      • Bruxelles, Belgio, 1070
      • Bruxelles, Belgio, 1000
      • Gent, Belgio, 9000
      • Kortrijk, Belgio, 8500
      • Liege, Belgio, 4000
  • Brasile
      • Brasilia, Brasile, 70335-000
      • Campinas, Brasile, 13081-970
      • Campinas, Brasile, 13012-970
      • Porto Alegre, Brasile, 90020-090
      • Porto Alegre, Brasile, 90035-003
      • Ribeirao Preto, Brasile, 14049-900
      • Rio de Janeiro, Brasile, 20020-022
      • Santo Andre, Brasile, 09060-650
      • Sao Luis, Brasile, 78048-790
      • Sao Paulo, Brasile, 04040-003
      • Sorocaba, Brasile, 18047-600
      • Vitoria, Brasile, 29043-260
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Mississauga, Ontario, Canada, L5M 4N4
  • Germania
      • Berlin, Germania, 13353
      • Berlin, Germania, 10969
      • Bonn, Germania, 53127
      • Düsseldorf, Germania, 40225
      • Düsseldorf, Germania, 40237
      • Frankfurt Am Main, Germania, 60590
      • Freiburg, Germania, 79106
      • Giessen, Germania, 35392
      • Hamburg, Germania, 20099
      • Heidelberg, Germania, 69120
      • Jena, Germania, 07747
      • Kiel, Germania, 24105
      • Köln, Germania, 50937
      • Mainz, Germania, 55101
      • München, Germania, 81675
      • Offenburg, Germania, 77654
      • Tübingen, Germania, 72076
      • ULM, Germania, 89081
  • Messico
      • Guadalajara, Messico, 44160
      • Guadalajara, Messico, 44670
      • Mexicali, Messico, 21000
      • Mexico City, Messico, 14050
      • Mexico Df, Messico, 11649
      • Puebla, Messico, 72560
  • Porto Rico
      • Santurce, Porto Rico, 00909
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
    • California
      • La Jolla, California, Stati Uniti, 92037-1030
      • Lancaster, California, Stati Uniti, 93534
      • Long Beach, California, Stati Uniti, 90822
      • Los Angeles, California, Stati Uniti, 90048
      • Los Angeles, California, Stati Uniti, 90057
      • Sacramento, California, Stati Uniti, 95817
      • Sacramento, California, Stati Uniti, 95816
      • San Diego, California, Stati Uniti, 92103-8465
      • Torrance, California, Stati Uniti, 90505
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32256
      • Orlando, Florida, Stati Uniti, 32803
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
      • Marietta, Georgia, Stati Uniti, 30060
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70890
      • Opelousas, Louisiana, Stati Uniti, 70520
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
    • Mississippi
      • Tupelo, Mississippi, Stati Uniti, 38801
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63110
      • St Louis, Missouri, Stati Uniti, 63104
    • New Jersey
      • Egg Harbour Township, New Jersey, Stati Uniti, 08234
      • Hackensack, New Jersey, Stati Uniti, 07601
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131
    • New York
      • New York, New York, Stati Uniti, 10016
      • Syracuse, New York, Stati Uniti, 13210
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28801
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7080
      • Winston-salem, North Carolina, Stati Uniti, 27103
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73112-4481
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
    • Tennessee
      • Kingsport, Tennessee, Stati Uniti, 37660
    • Texas
      • Fort Sam Houston, Texas, Stati Uniti, 78234-3879
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84132
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
      • Fairfax, Virginia, Stati Uniti, 22031
      • Richmond, Virginia, Stati Uniti, 23249
  • Svizzera
      • Lausanne, Svizzera, 1005
      • Lugano, Svizzera, 6903
      • St. Gallen, Svizzera, 9007
      • Zürich, Svizzera, 8091

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
  • history or other evidence of decompensated liver disease.

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: PEG-IFN alfa-2a + Ribavirin for 24 weeks
After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
Droga: Ribavirina
Altri nomi:
  • Copego®
Droga: peginterferone alfa-2a
Altri nomi:
  • Pegasys®
  • PEG-IFN alfa-2a
Comparatore attivo: PEG-IFN alfa-2a + Ribavirin for 48 weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Droga: Ribavirina
Altri nomi:
  • Copego®
Droga: peginterferone alfa-2a
Altri nomi:
  • Pegasys®
  • PEG-IFN alfa-2a

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Lasso di tempo: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.

Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
Lasso di tempo: 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
24 weeks after actual end of treatment (range from Week 48 to Week 72).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Lasso di tempo: Week 72

Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.

Participants without Week 72 measurements were considered non-responders in the analysis.
Week 72
Percentage of Participants With Virological Response at End of Treatment
Lasso di tempo: End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Percentage of Participants With Virological Relapse
Lasso di tempo: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).

Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.

Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.

Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.
End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
Lasso di tempo: 12 weeks after actual end of treatment (range from Week 36 to Week 60)
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
12 weeks after actual end of treatment (range from Week 36 to Week 60)
Number of Participants With Adverse Events (AEs)
Lasso di tempo: From Week 1 through Week 72.
An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
From Week 1 through Week 72.

Collaboratori e investigatori

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

Sponsor

Hoffmann-La Roche

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 giugno 2008

Completamento primario (Effettivo)

1 maggio 2012

Completamento dello studio (Effettivo)

1 maggio 2012

Date di iscrizione allo studio

Primo inviato

18 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

18 febbraio 2008

Primo Inserito (Stima)

26 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 luglio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2013

Ultimo verificato

1 luglio 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MV21371
  • 2007-004993-15

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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