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

Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

3. juni 2014 opdateret af: National Taiwan University Hospital

Peginterferon Alfa-2a Plus Ribavirin in Patients With Genotype 2 Chronic Hepatitis C: A Randomized Study of Treatment Duration and Ribavirin Dose Stratified by Rapid Virologic Response

Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) RNA levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% vs. 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. We aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

880

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Douliou, Taiwan
        • National Taiwan University Hospital, Yun-Lin Branch
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University
      • Kaohsiung, Taiwan
        • Kaohsiung Municipal Hsiao-Kang Hospital
      • Pingtung, Taiwan
        • Paochien Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • Ren-Ai Branch, Taipei Municipal Hospital
      • Taipei, Taiwan
        • Buddhist Xindian Tzu Chi General Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Treatment naïve
  • Age older than 18 years old
  • Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
  • Detectable serum quantitative HCV-RNA (Cobas Taqman HCV Monitor v2.0, Roche Diagnostics) with dynamic range 25 ~ 391000000 IU/ml
  • HCV genotype 2 (Inno-LiPA HCV II, Innogenetics, Ghent, Belgium)
  • Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
  • A liver biopsy consistent with the diagnosis of chronic hepatitis C

Exclusion Criteria:

  • Anemia (hemoglobin < 13 grams per deciliter for men and < 12 grams per deciliter for women)
  • Neutropenia (neutrophil count < 1,500 per cubic milliliter)
  • Thrombocytopenia (platelets < 90,000 per cubic milliliter)
  • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic alcohol abuse (daily consumption > 20 grams per day)
  • Decompensated liver disease (Child-Pugh class B or C)
  • Serum creatinine level more than 1.5 times the upper limit of normal
  • Autoimmune liver disease
  • Neoplastic disease
  • An organ transplant
  • Immunosuppressive therapy
  • Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
  • Evidence of drug abuse
  • Unwilling to use contraception
  • Unwilling to sign informed consent

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: Peg-IFN + WB RBV for 16 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-16 in patients with RVR
Medicin: Peg-IFN + WB RBV for 16 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 5-16
Andre navne:
  • Pegasys plus Copegus
Aktiv komparator: Peg-IFN + LD RBV for 16 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-6, and then low dose ribavirin (800 mg/day) from weeks 6-16 in patients with RVR
Medicin: Peg-IFN + LD RBV for 16 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-6
  2. Rapid virologic response (RVR) at week 4 of therapy: achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16
Andre navne:
  • Pegasys plus Copegus
Aktiv komparator: Peg-IFN + WB RBV for 24 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-24 in patients without RVR
Medicin: Peg-IFN + WB RBV for 24 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: not achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24
Andre navne:
  • Pegasys plus Copegus
Aktiv komparator: Peg-IFN + WB RBV for 48 weeks
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-48 in patients without RVR
Medicin: Peg-IFN + WB RBV for 48 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
  2. Rapid virologic response (RVR) at week 4 of therapy: not achieved
  3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48
Andre navne:
  • Pegasys plus Copegus
Aktiv komparator: Peg-IFN + LD RBV for 24 weeks
Low dose ribavirin (800 mg/day) from weeks 1-24 in patients with or without RVR
Medicin: Peg-IFN + LD RBV for 24 weeks
  1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24
  2. Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved
Andre navne:
  • Pegasys plus Copegus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sustained virologic response (SVR)
Tidsramme: 1.5 year
1.5 year

Sekundære resultatmål

Resultatmål
Tidsramme
Histologic response (HR)
Tidsramme: 1.5 year
1.5 year
Biochemical response (BR)
Tidsramme: 1.5
1.5

Samarbejdspartnere og efterforskere

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

Sponsor

National Taiwan University Hospital

Samarbejdspartnere

National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)

Efterforskere

  • Ledende efterforsker: Chun-Jen Liu, MD, PhD, National Taiwan University Hospital
  • Ledende efterforsker: Chen-Hua Liu, MD, National Taiwan University Hospital
  • Ledende efterforsker: Wan-Long Chuang, MD, PhD, Kaohsiung Medical University
  • Ledende efterforsker: Pei-Jer Chen, MD, PhD, National Taiwan University Hospital
  • Ledende efterforsker: Sheng-Shun Yang, MD, Taichung Veterans General Hospital
  • Ledende efterforsker: Ding-Shinn Chen, MD, National Taiwan University Hospital
  • Ledende efterforsker: Chia-Yen Dai, MD, Ms, Kaohsiung Municipal Hsiao-Kang Hospital
  • Ledende efterforsker: Chang-Fu Chiu, MD, Paochien Hospital
  • Ledende efterforsker: Ming-Yang Lai, MD, PhD, National Taiwan University Hospital
  • Ledende efterforsker: Chih-Lin Lin, MD, Taipei City Hospital, Ren-Ai Branch
  • Ledende efterforsker: Ching-Sheng Hsu, MD, Buddhist Xindian Tzu Chi General Hospital
  • Ledende efterforsker: Chia-Chi Wang, MD, Buddhist Xindian Tzu Chi General Hospital
  • Ledende efterforsker: Tai-Chung Tseng, MD, Buddhist Xindian Tzu Chi General Hospital

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 2007

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

18. september 2007

Først indsendt, der opfyldte QC-kriterier

18. september 2007

Først opslået (Skøn)

20. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 200709014M

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 Peg-IFN + WB RBV for 16 weeks

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kosovo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner