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A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

23 giugno 2016 aggiornato da: Hoffmann-La Roche

A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

896

Fase

  • Fase 4

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

  • Argentina
      • Buenos Aires, Argentina, 1640
      • Buenos Aires, Argentina, C1282AFE
      • La Plata, Argentina, B1902AVF
      • Rosario, Argentina, 2000
  • Australia
      • Adelaide, Australia, 5000
      • Adelaide, Australia, 5042
      • Bankstown, Australia, 2200
      • Box Hill, Australia, 3128
      • Brisbane, Australia, 4029
      • Cottontree, Australia, 4558
      • Darlinghurst, Australia, 2010
      • Douglas, Australia
      • Fitzroy, Australia, 3065
      • Fremantle, Australia, 6160
      • Geelong, Australia, 3220
      • Greenslopes, Australia, 4120
      • Kingswood, Australia
      • Lismore, Australia, 2480
      • Liverpool, Australia, 1871
      • Liverpool, Australia, 2170
      • Melbourne, Australia, 3181
      • Melbourne, Australia, 3084
      • Melbourne, Australia, 3011
      • Melbourne, Australia, 3186
      • Miranda, Australia, 2228
      • Nedlands, Australia, 6009
      • New Lambton Heights, Australia, 2310
      • Parkville, Australia, 3052
      • Perth, Australia, 6001
      • Sydney, Australia, 2050
      • Sydney, Australia, 2145
      • Sydney, Australia, 2139
      • Sydney, Australia, 2010
      • Victoria, Australia, 3199
      • Woden, Australia, 2606
      • Wollongong, Australia, 2500
      • Woolloongabba, Australia, 4102
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
      • Edmonton, Alberta, Canada, T5H 4B9
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Messico
      • Guadalajara, Messico, 44650
      • Guadalajara, Messico, 44280
      • Monterrey, Messico, 64460
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 100
      • Hamilton, Nuova Zelanda
      • Riccarton, Christchurch, Nuova Zelanda, 8011
  • Tailandia
      • Bangkok, Tailandia, 10400
      • Bangkok, Tailandia, 10700
      • Chiang Mai, Tailandia, 50202

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 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of chronic CHC, genotype 1
  • Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
  • Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
  • Compensated liver disease
  • Naive to interferon-based therapy for CHC infection

Exclusion Criteria:

  • Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
  • Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
  • Chronic liver disease other than CHC infection

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: PEG-IFN alfa-2a+Ribavirin - Induction Treatment
Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Droga: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Altri nomi:
  • Pegasys
Droga: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Altri nomi:
  • Copego
Sperimentale: PEG-IFN alfa-2a+Ribavirin - Standard Treatment
Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Droga: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Altri nomi:
  • Pegasys
Droga: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Altri nomi:
  • Copego

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Lasso di tempo: Week 72
Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
Week 72

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Lasso di tempo: Weeks 48
Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.
Weeks 48
Percentage of Participants With Virological Responses Over Time
Lasso di tempo: Weeks 4, 8, 12, and 24
Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.
Weeks 4, 8, 12, and 24
Percentage of Participants With Relapse of End-of-treatment Virological Response
Lasso di tempo: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.
Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Lasso di tempo: Weeks 4, 12, and 72
The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.
Weeks 4, 12, and 72
Change From Baseline in Log10 HCV RNA Values
Lasso di tempo: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

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 agosto 2004

Completamento primario (Effettivo)

1 marzo 2009

Completamento dello studio (Effettivo)

1 marzo 2009

Date di iscrizione allo studio

Primo inviato

13 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2005

Primo Inserito (Stima)

19 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2016

Ultimo verificato

1 giugno 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML17908

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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