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Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C (INTEGRATE)

1 mars 2017 uppdaterad av: Janssen Pharmaceutica N.V., Belgium

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

The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

This is a multicenter, non-interventional, observational, prospective study to evaluate the efficacy, safety, and adherence to telaprevir in ex-People Who Inject Drugs (ex-PWIDs) infected with genotype 1 chronic hepatitis C and any fibrosis stage including compensated cirrhosis, who are receiving substitution therapy (eg, methadone, buprenorphine) and/or are being followed in an addiction center. Patients may be treatment naïve or relapsers. Participating physicians are to offer enrollment in this study to all eligible patients at their site in who they plan to initiate triple therapy with telaprevir, pegylated interferon alfa (PegIFN alfa), and ribavirin (RBV). A target of 115 patients will participate in this study. The duration of each patient's participation in this study will be up to approximately 60 weeks. After obtaining the signed participation agreement or ICF, selection criteria will be reviewed to verify the patient's eligibility. Data will be recorded in the electronic case report form (CRF) at 6 time points for each patient which correspond to routine care visits: inclusion, and at the patient's routine care visit closest to Week 4, 12, and 24, end of treatment, and end-of-follow-up (e.g., approximately 12 weeks after end-of-treatment). No additional blood, urine, or other biological samples will be required, and no additional investigations, beyond the routine clinical management of the patient, will be performed.

Studietyp

Observationell

Inskrivning (Faktisk)

50

Kontakter och platser

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

Studieorter

  • Belgien
      • Antwerpen, Belgien
      • Brussels, Belgien
      • Bruxelles, Belgien
      • Genk, Belgien
      • Haine-Saint-Paul, Belgien
  • Frankrike
      • Lomme, Frankrike
      • Montpellier, Frankrike
      • Perpignan Cedex, Frankrike
  • Nederländerna
      • Maastricht, Nederländerna
  • Schweiz
      • Lausanne, Schweiz
      • Zürich, Schweiz
  • Storbritannien
      • Dundee, Storbritannien
      • London, Storbritannien
      • Nottingham, Storbritannien
  • Tyskland
      • Berlin, Tyskland
      • Biberach, Tyskland
      • Kassel, Tyskland
      • München, Tyskland
      • Münster, Tyskland

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

Men or women who have HCV infection genotype 1, a quantifiable serum HCV RNA, documentation of the degree of liver fibrosis 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), have a history of injecting drugs, and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center will be eligible to enter this study.

Beskrivning

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.

Studieplan

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

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sustained Virologic Response at 12 weeks (SVR12)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
adherence to telaprevir until Week 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

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

Sponsor

Janssen Pharmaceutica N.V., Belgium

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

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 maj 2013

Primärt slutförande (Faktisk)

1 februari 2015

Avslutad studie (Faktisk)

1 februari 2015

Studieregistreringsdatum

Först inskickad

4 november 2013

Först inskickad som uppfyllde QC-kriterierna

4 november 2013

Första postat (Uppskatta)

8 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR100966
  • VX-950HPC4017 (Annan identifierare: Janssen Pharmaceutica NV - CTMS ID)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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