Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (PEGHOPE)

10 maart 2017 bijgewerkt door: Hoffmann-La Roche

A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life

This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

Studie Overzicht

Toestand

Voltooid

Conditie

Hepatitis C, chronisch

Studietype

Observationeel

Inschrijving (Werkelijk)

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

Oostenrijk
- - Gratwein, Oostenrijk, 8112
    - Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
  - Graz, Oostenrijk, 8036
    - Lkh-Univ. Klinikum Graz
  - Innsbruck, Oostenrijk, 6020
    - Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
  - Klagenfurt, Oostenrijk, 9020
    - Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
  - Linz, Oostenrijk, 4010
    - A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
  - Wien, Oostenrijk, 1090
    - Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
  - Wien, Oostenrijk, 1030
    - Gesundheitszentrum Wien Mitte
  - Wien, Oostenrijk, 1030
    - Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.
  - Wien, Oostenrijk, 1100
    - Kaiser Franz Josef Spital; Iv. Medizinische Abt.
  - Wien, Oostenrijk, 1160
    - Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung

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

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

Beschrijving

Inclusion Criteria:

Adult participants, >/= 18 years of age
Participants undergoing an opioid maintenance therapy
Serologic evidence of CHC prior to therapy
CHC genotype 2, 3, 1 or 4
Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment

Exclusion Criteria:

Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
Current diagnosis of a major depression or any psychotic disorder

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

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
All Participants Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) Tijdsspanne: 24 weeks after completing treatment, within 3 years, 6 months	SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).	24 weeks after completing treatment, within 3 years, 6 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percentage of Participants With SVR 12 Tijdsspanne: 12 weeks after completing treatment, within 3 years, 6 months	SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).	12 weeks after completing treatment, within 3 years, 6 months
Percentage of Participants With End of Treatment Response Tijdsspanne: at end of treatment, within 3 years, 6 months	A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).	at end of treatment, within 3 years, 6 months
Percentage of Participants With Virological Relapse Tijdsspanne: by end of follow-up, within 3 years, 6 months	Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).	by end of follow-up, within 3 years, 6 months
Short Form Health Survey (SF-36) Scores by Visit Tijdsspanne: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months	The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.	at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Fatigue Severity Scale (FSS) Score by Visit Tijdsspanne: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months	The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.	at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Beschwerdeliste (BL) Score by Visit Tijdsspanne: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months	The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.	at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Beck Depression Inventory (BDI) Score by Visit Tijdsspanne: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months	The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.	at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months

Medewerkers en onderzoekers

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

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Gschwantler M, Laferl H, Vogel W, Korak W, Moser S, Hofer H, Bauer B, Schleicher M, Bognar B, Bischof M, Stauber R, Maieron A, Ferenci P; Austrian Hepatitis Study Group. Efficacy of peginterferon plus ribavirin in patients receiving opioid substitution therapy : Final results of the Austrian PegHope study. Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12.

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 april 2010

Primaire voltooiing (Werkelijk)

1 oktober 2014

Studie voltooiing (Werkelijk)

1 oktober 2014

Studieregistratiedata

Eerst ingediend

12 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria