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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

896

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • 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
  • Mexico
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44280
      • Monterrey, Mexico, 64460
  • New Zealand
      • Auckland, New Zealand, 100
      • Hamilton, New Zealand
      • Riccarton, Christchurch, New Zealand, 8011
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50202

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2004

Primær færdiggørelse (Faktiske)

1. marts 2009

Studieafslutning (Faktiske)

1. marts 2009

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

19. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML17908

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Kliniske forsøg med Hepatitis C, kronisk

Kliniske forsøg med PEG-IFN alfa-2a

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Placeringer

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