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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 juli 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

235

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Ribavirine
Andere namen:
  • Copegus®
Geneesmiddel: peginterferon alfa-2a
Andere namen:
  • Pegasys®
  • PEG-IFN alfa-2a
Actieve vergelijker: 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.
Geneesmiddel: Ribavirine
Andere namen:
  • Copegus®
Geneesmiddel: peginterferon alfa-2a
Andere namen:
  • Pegasys®
  • PEG-IFN alfa-2a

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Tijdsspanne: 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
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2008

Primaire voltooiing (Werkelijk)

1 mei 2012

Studie voltooiing (Werkelijk)

1 mei 2012

Studieregistratiedata

Eerst ingediend

18 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

18 februari 2008

Eerst geplaatst (Schatting)

26 februari 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

22 juli 2013

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2013

Laatst geverifieerd

1 juli 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MV21371
  • 2007-004993-15

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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