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A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

5. juli 2016 oppdatert av: Hoffmann-La Roche

A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

114

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hellas
      • Aigaleo - Attiki, Hellas, 12241
      • Athens, Hellas, 115 27
      • Athens, Hellas, 11527
      • Athens, Hellas, 11528
      • Athens, Hellas, 11522
      • Athens, Hellas, 11526
      • Heraklion, Hellas, 71100
      • Piraeus, Hellas, 18536
      • Piraeus, Hellas, 18454
      • Thessaloniki, Hellas, 546 42

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants with CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

Beskrivelse

Inclusion Criteria:

  • Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
  • HCV ribonucleic acid (RNA) positive
  • CHC with normal transaminases
  • Compensated liver disease
  • Non-pregnant and willing to use two contraceptive methods (if fertile)
  • At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

  • Pregnant or lactating women
  • Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
  • History of seizures or depression
  • History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
  • Uncontrolled thyroid disease
  • Severe retinopathy
  • Leukopenia or thrombocytopenia
  • Bleeding esophageal varices or other evidence of hepatic decompensation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
Legemiddel: Peginterferon alfa-2a
As per treating physician discretion and according to summary of product characteristics.
Andre navn:
  • Pegasys
Legemiddel: Ribavirin
As per treating physician discretion and according to summary of product characteristics.
Andre navn:
  • Copegus

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Tidsramme: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Tidsramme: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Tidsramme: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Tidsramme: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Tidsramme: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Tidsramme: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2007

Primær fullføring (Faktiske)

1. juli 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

29. mars 2016

Først innsendt som oppfylte QC-kriteriene

29. mars 2016

Først lagt ut (Anslag)

1. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juli 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML20151

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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