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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 mars 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Hépatite C chronique

Type d'étude

Observationnel

Inscription (Réel)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants With SVR 12 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2010

Achèvement primaire (Réel)

1 octobre 2014

Achèvement de l'étude (Réel)

1 octobre 2014

Dates d'inscription aux études

Première soumission

12 août 2011

Première soumission répondant aux critères de contrôle qualité