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

HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

9. september 2016 opdateret af: Hoffmann-La Roche

A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis

This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Brasilien
      • Brasilia, Brasilien, 70335-000
      • Porto Alegre, Brasilien, 90035-003
      • Sao Jose Rio Preto, Brasilien, 15090-003
      • Sao Luis, Brasilien, 78048-790
      • Sao Paulo, Brasilien, 04023-900
  • Forenede Arabiske Emirater
      • Abu Dhabi, Forenede Arabiske Emirater
  • Frankrig
      • Creteil, Frankrig, 94010
      • Le Kremlin-bicetre, Frankrig, 94275
      • Marseille, Frankrig, 13385
      • Paris, Frankrig, 75747
      • Strasbourg, Frankrig, 67091
      • Toulouse, Frankrig, 31059
  • Grækenland
      • Athens, Grækenland, 11527
      • Nikea, Grækenland, 18354
  • Indonesien
      • Medan, Indonesien, 20119
  • Italien
      • Cagliari, Italien, 09134
  • Kalkun
      • Istanbul, Kalkun, 34303
      • Istanbul, Kalkun, 34390
      • Istanbul, Kalkun, 34662
      • Izmir, Kalkun, 35040
  • Østrig
      • Graz, Østrig, 8036
      • Wien, Østrig, 1090

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (>) 600 IU/mL
  • Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
  • Compensated liver disease without cirrhosis
  • Participants with end-stage renal disease undergoing hemodialysis
  • Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile participants must have been using effective contraception during treatment with study drug

Exclusion Criteria:

  • Interferon therapy at any previous time
  • Liver cirrhosis
  • Signs and symptoms of hepatocellular carcinoma
  • History or other evidence of decompensated liver disease
  • Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Poorly controlled diabetes
  • Thyroid dysfunction not adequately controlled
  • Evidence of severe retinopathy or clinically relevant ophthalmological disorder
  • Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) > 800 picogram/milliliter (pg/mL)
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
  • Acute renal failure
  • Women with ongoing pregnancy or breast feeding
  • Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab

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
Eksperimentel: Peginterferon alfa-2a 135 microgram (mcg)
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
Medicin: Peginterferon alfa-2a
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
Andre navne:
  • Pegasys
Eksperimentel: Peginterferon alfa-2a 90 mcg
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
Medicin: Peginterferon alfa-2a
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
Andre navne:
  • Pegasys

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
Tidsramme: 24 weeks after end of treatment (Week 72)
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
24 weeks after end of treatment (Week 72)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
Tidsramme: EOT (Week 48)
Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.
EOT (Week 48)
Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24
Tidsramme: Weeks 12 and 24
Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.
Weeks 12 and 24

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. juni 2004

Primær færdiggørelse (Faktiske)

1. august 2007

Studieafslutning (Faktiske)

1. august 2007

Datoer for studieregistrering

Først indsendt

16. juni 2016

Først indsendt, der opfyldte QC-kriterier

16. juni 2016

Først opslået (Skøn)

20. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MV17149

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 Hepatitis C, kronisk

Kliniske forsøg med Peginterferon alfa-2a

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner