Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (DARGEN-3)

12. marts 2012 opdateret af: Dr. Conrado Fernandez

Effect of High Dose vs. Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3, High Viral Load Without Rapid Virological Response

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Aims:

  1. Efficacy 1.1) Rate of RNA-HCV negative at week 4 and 24 in each arm. 1.2) Rate of SVR in each arm.
  2. Safety 2.1) Rate of adverse effects in each arm.

Design: Randomized controlled trial.

Patients will be randomly allocated into three arms:

Arm A : Peginterferon α-2a (180 μg/week)SC. plus Ribavirin (800 mg/day) p.o. over 24 weeks.

Arm B: Peginterferon α-2a (180 μg/week) plus Ribavirin (1600 mg/day) with support of Epoetin β (450 IU/kg/week) SC over 4 weeks:

B1.- If RNA-HCV undetectable at week 4, standard of care will be continued (Peginterferon α-2a, 180 μg/wee plus Ribavirin (800 mg/day) over 20 additional weeks).

B2.- If RNA-HCV were detectable at week 4, treatment will be continued with peginterferon α-2a (180 μg/week) plus RBV(1,600 mg/day) plus Epoetin β (450 UI/kg/week) over 20 additional weeks.

Sample size: 111 patients. To increase the SVR from 50% to 75%. Beta: 0.1; alfa: 0.05; Loss: 15%.

Randomization will be 1:2, 37 patients in Group A and 74 patients in group B.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Spanien
      • Barcelona, Spanien, 08003
        • Hospital Del Mar
      • Barcelona, Spanien, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Córdoba, Spanien, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spanien
        • Hospital San Cecilio
      • Granada, Spanien, 18004
        • Hospital Universitario Virgen de las Nieves
      • León, Spanien, 24071
        • Hospital de Leon
      • Madrid, Spanien, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spanien, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spanien, 28006
        • Hospital La Princesa
      • Madrid, Spanien, 28021
        • Hospital 12 de Octubre
      • Málaga, Spanien, 29010
        • Hospital Clínico Universitario Virgen de la Victoria
      • Oviedo, Spanien, 33006
        • Hospital Central de Asturias
      • Salamanca, Spanien, 37007
        • Hospital Clínico Universitario de Salamanca
      • Santander, Spanien, 39008
        • Hospital Marques de Valdecilla
      • Sevilla, Spanien, 41014
        • Hospital De Valme
      • Valencia, Spanien, 46010
        • Hospital Clínico Universitario de Valencia
      • Valladolid, Spanien, 47005
        • Hospital Clinico Universitario de Valladolid
      • Vitoria, Spanien, 01004
        • Hospital Santiago Apostol
      • Zaragoza, Spanien, 50009
        • Hospital Miguel Servet
      • Zaragoza, Spanien, 50009
        • Hospital Clínico de Zaragoza
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Hospital Germans Trias i Pujol
      • L´Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Hospital De Bellvitge
      • Sabadell, Barcelona, Spanien, 08208
        • Hospital Parc Tauli
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spanien, 20014
        • Hospital de Donostia
    • Madrid
      • Alcorcón, Madrid, Spanien, 28922
        • Hospital Fundación Alcorcón
      • Getafe, Madrid, Spanien, 28901
        • Hospital de Getafe
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Puerta de Hierro
    • Málaga
      • Marbella, Málaga, Spanien, 29603
        • Hospital Costa del Sol

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • HCV Genotype 3
  • RNA-HCV > > 600.000 IU/ml.
  • Compromise to use contraceptive measures on treatment until 6 months after the end of treatment.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Concurrent treatment with antineoplastic or immunomodulatory agents, including corticosteroids or radiation therapy over the last 6 months before starting the trial
  • Treatment with investigational drugs < 6 weeks before starting the trial
  • Chronic liver disease other than hepatitis C.
  • Evidence of hepatocellular carcinoma.
  • Evidence of carcinoma hepatocellular
  • Decompensated liver disease
  • Baseline Neutrophil count < 1500/cc; or Platelet count < 90,000/cc
  • Baseline Hemoglobin <12 g/dL in females o <13 g/dL in males.
  • Increased risk of anemia(Eg, thalassemia, spherocytosis..).
  • Ischemic heart disease or cerebrovascular disease.
  • Serum creatinine >1.5 times upper limit of normality.
  • History of severe psychiatric conditions (Major antidepressives or neuroleptic drugs required for major depression or psychosis), suicide attempts or psychiatric disability .
  • History of convulsive disorders.
  • Immunological conditions.
  • Chronic Obstructive Lung Disease with limited functionality
  • Severe heart disease or congestive cardiac insufficiency cardiopathy grave.
  • Advanced atherosclerosis
  • Solid organ or bone marrow transplant.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: A
Patients in this arm will receive standard of care (Peginterferon alfa 2A 180 mcg/weeks SC plus ribavirin 800 mg/day for 24 weeks).
Medicin: Peginterferon alfa 2 A
Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb>12 g/dL if required over 20 additional weeks (Arm B2)
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 24 weeks
Andre navne:
  • peginterferon alfa 2 a
  • Epoetin beta
Medicin: ribavirin
ribavirin 800 mg/day for 24 weeks
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks
Andre navne:
  • Pegasys
Eksperimentel: B1
After a period of 4 weeks with peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day (Induction phase), these patients will be allocated according to negativity or positivity of RNA-HCV at week 4. If RNA-HCV negative, treatment with peginterferon alfa 2 a 180 mcg/week plus RBV 800 mg/day (SOC) will be continued over 20 additional weeks (Arm B1). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin > 12g/dL.
Medicin: Peginterferon alfa 2 A
Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb>12 g/dL if required over 20 additional weeks (Arm B2)
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 24 weeks
Andre navne:
  • peginterferon alfa 2 a
  • Epoetin beta
Medicin: ribavirin
ribavirin 800 mg/day for 24 weeks
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks
Andre navne:
  • Pegasys
Medicin: Peginterferon alfa 2 A, ribavirin + Epo Beta
Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb>12g/dl over 4 or 24 weeks
Andre navne:
  • Pegasys
Medicin: Peginterferon alfa 2
Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks
Andre navne:
  • Pegasys
Eksperimentel: B2
If RNA-HCV at week 4 remains positive after the induction phase, then peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day will be continued for 20 additional weeks (Arm B2). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin > 12g/dL.
Medicin: Peginterferon alfa 2 A
Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb>12 g/dL if required over 20 additional weeks (Arm B2)
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 24 weeks
Andre navne:
  • peginterferon alfa 2 a
  • Epoetin beta
Medicin: ribavirin
ribavirin 800 mg/day for 24 weeks
Andre navne:
  • Pegasys
Medicin: ribavirin
RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks
Andre navne:
  • Pegasys
Medicin: Peginterferon alfa 2 A, ribavirin + Epo Beta
Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb>12g/dl over 4 or 24 weeks
Andre navne:
  • Pegasys

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Rate of patients with undetectable RNA-HCV in each arm at week 4 and 24 of treatment. Rate of adverse effects in each arm.
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Dr. Conrado Fernandez

Efterforskere

  • Studieleder: Conrado M Fernandez-Rodriguez, Hospital Universitario Fundacion Alcorcon; University Rey Juan Carlos.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. november 2008

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

27. januar 2009

Først indsendt, der opfyldte QC-kriterier

27. januar 2009

Først opslået (Skøn)

28. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ROCHE FARMA S.A.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk hepatitis C

Kliniske forsøg med Peginterferon alfa 2 A

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Liberia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner