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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Hepatit C, kronisk

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Percentage of Participants With SVR 12 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2010

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Faktisk)

1 oktober 2014

Studieregistreringsdatum

Först inskickad

12 augusti 2011

Först inskickad som uppfyllde QC-kriterierna