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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 juni 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

896

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Andra namn:
  • Pegasys
Läkemedel: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Andra namn:
  • Copegus
Experimentell: 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.
Läkemedel: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Andra namn:
  • Pegasys
Läkemedel: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Andra namn:
  • Copegus

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2004

Primärt slutförande (Faktisk)

1 mars 2009

Avslutad studie (Faktisk)

1 mars 2009

Studieregistreringsdatum

Först inskickad

13 september 2005

Först inskickad som uppfyllde QC-kriterierna

13 september 2005

Första postat (Uppskatta)

19 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 augusti 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2016

Senast verifierad

1 juni 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ML17908

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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