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 marzo 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
88
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Gratwein, Austria, 8112
- Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
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Graz, Austria, 8036
- Lkh-Univ. Klinikum Graz
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Innsbruck, Austria, 6020
- Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
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Klagenfurt, Austria, 9020
- Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
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Linz, Austria, 4010
- A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
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Wien, Austria, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
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Wien, Austria, 1030
- Gesundheitszentrum Wien Mitte
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Wien, Austria, 1030
- Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.
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Wien, Austria, 1100
- Kaiser Franz Josef Spital; Iv. Medizinische Abt.
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Wien, Austria, 1160
- Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
Lasso di tempo: 24 weeks after completing treatment, within 3 years, 6 months
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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).
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24 weeks after completing treatment, within 3 years, 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With SVR 12
Lasso di tempo: 12 weeks after completing treatment, within 3 years, 6 months
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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).
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12 weeks after completing treatment, within 3 years, 6 months
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Percentage of Participants With End of Treatment Response
Lasso di tempo: at end of treatment, within 3 years, 6 months
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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).
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at end of treatment, within 3 years, 6 months
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Percentage of Participants With Virological Relapse
Lasso di tempo: by end of follow-up, within 3 years, 6 months
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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).
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by end of follow-up, within 3 years, 6 months
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Short Form Health Survey (SF-36) Scores by Visit
Lasso di tempo: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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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.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Fatigue Severity Scale (FSS) Score by Visit
Lasso di tempo: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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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.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Beschwerdeliste (BL) Score by Visit
Lasso di tempo: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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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.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Beck Depression Inventory (BDI) Score by Visit
Lasso di tempo: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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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.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2010
Completamento primario (Effettivo)
1 ottobre 2014
Completamento dello studio (Effettivo)
1 ottobre 2014
Date di iscrizione allo studio
Primo inviato
12 agosto 2011
Primo inviato che soddisfa i criteri di controllo qualità
12 agosto 2011
Primo Inserito (Stima)
15 agosto 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 aprile 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 marzo 2017
Ultimo verificato
1 marzo 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite cronica
- Epatite
- Epatite A
- Epatite C
- Epatite C, cronica
Altri numeri di identificazione dello studio
- ML25159
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .