- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01980290
Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C (INTEGRATE)
Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Antwerpen, Belgien
-
Brussels, Belgien
-
Bruxelles, Belgien
-
Genk, Belgien
-
Haine-Saint-Paul, Belgien
-
-
-
-
-
Berlin, Deutschland
-
Biberach, Deutschland
-
Kassel, Deutschland
-
München, Deutschland
-
Münster, Deutschland
-
-
-
-
-
Lomme, Frankreich
-
Montpellier, Frankreich
-
Perpignan Cedex, Frankreich
-
-
-
-
-
Maastricht, Niederlande
-
-
-
-
-
Lausanne, Schweiz
-
Zürich, Schweiz
-
-
-
-
-
Dundee, Vereinigtes Königreich
-
London, Vereinigtes Königreich
-
Nottingham, Vereinigtes Königreich
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.
Exclusion Criteria:
Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sustained Virologic Response at 12 weeks (SVR12)
Zeitfenster: Week 12
|
HCV RNA <25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
|
Week 12
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
adherence to telaprevir until Week 12
Zeitfenster: week 12
|
adherence as measured by pill count and/or patient questionnaire (modified medication adherence self-report inventory [M-MASRI]
|
week 12
|
adherence to PegIFN alfa and RBV
Zeitfenster: at end of treatment (week 24)
|
adherence as measured by pill/vial count and/or patient questionnaire (M-MASRI)
|
at end of treatment (week 24)
|
on-treatment virologic response undetectable
Zeitfenster: week 12 and end of treatment ()
|
rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL undetectable
|
week 12 and end of treatment ()
|
on treatment virologic response
Zeitfenster: week 12 and end of treatment ()
|
rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL
|
week 12 and end of treatment ()
|
health-related quality of life based on EQ-5D
Zeitfenster: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses.
The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems).
A standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state is also included ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
|
on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
HADS is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression.
Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety.
Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0-7), mild (score of 8-10), moderate (score of 11-14), and severe (score of 15-21).
The recall period is the past week.
|
on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
alcohol use disorders identification test (AUDIT)
Zeitfenster: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
The AUDIT questionnaire consists of 10 questions about a patient's quantity and frequency of alcohol use.
The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week.
Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year.
A score of 8 or more is associated with harmful or hazardous drinking
|
on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Flaviviridae-Infektionen
- Hepatitis, viral, menschlich
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, chronisch
- Hepatitis C, chronisch
Andere Studien-ID-Nummern
- CR100966
- VX-950HPC4017 (Andere Kennung: Janssen Pharmaceutica NV - CTMS ID)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Hepatitis, chronisch
-
Gilead SciencesAbgeschlossenChronische Hepatitis DeltaFrankreich, Moldawien, Republik, Rumänien, Russische Föderation
-
University of Maryland, BaltimoreAlexandria University; MADAUS GmbH; The Egyptian Company for Blood Transfusion... und andere MitarbeiterBeendetAkute Hepatitis C | Akute Hepatitis B | Akute Hepatitis A | Akute Hepatitis E | Akute EBV-Hepatitis | Akute CMV-HepatitisÄgypten
-
Ziauddin HospitalUnbekannt
-
Eiger BioPharmaceuticalsAbgeschlossenChronische Hepatitis-D-InfektionTruthahn
-
Hepatera Ltd.AbgeschlossenChronische Hepatitis-D-Infektion
-
Hoffmann-La RocheBeendet
-
AbbVieAbgeschlossenHepatitis-C-Virus | Chronisches Hepatitis-C-Virus
-
National Taiwan University HospitalNational Science Council, Taiwan; National Health Research Institutes, TaiwanUnbekanntChronische Hepatitis B | Chronische Hepatitis DTaiwan
-
Beijing Kawin Technology Share-Holding Co., Ltd.AbgeschlossenChronische Hepatitis cChina
-
Eiger BioPharmaceuticalsZurückgezogenChronische Delta-Hepatitis