Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period

6 maj 2016 uppdaterad av: Bristol-Myers Squibb

Using European data from patients included in the Named Patient Program (NPP) and from the early post-marketing authorization period, the present study aims to describe patient characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in Europe. This will be a retrospective cohort study of patients who received treatment with a DCV-based regimen in the following context:

  • Patients enrolled within the European NPP in one of the following countries Austria, Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or
  • In those countries where DCV is commercially available (ie, Sweden, Germany, United Kingdom), patients who received DCV during the early post-marketing authorization period

The results of this study will contribute to a better understanding of effectiveness of DCV-based regimens in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice.

This study intends to estimate primarily the effectiveness of DCV-based regimens as measured by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end of Hepatitis C virus (HCV).

This study intends also to describe as secondary objectives the characteristics (ie, demographic and clinical characteristics and treatment patterns of patients starting a new DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based regimens as measured by:

  • On-treatment virological response at post treatment follow-up visit Week 4; and
  • Virological response at the end of treatment (EOT); and
  • The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post treatment follow-up visit Week 24 (SVR24); and
  • The occurrence of virological failure (on-treatment and relapse).

An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the overall population treated with DCV.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

249

Kontakter och platser

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

Studieorter

  • Schweiz
      • Basel, Schweiz
        • Local Institution

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

Icke-sannolikhetsprov

Studera befolkning

The study population was selected from European HCV registries or databases in specific health-care facilities from Austria, Denmark, Italy, Sweden, Spain, Switzerland, and United Kingdom (UK)

Beskrivning

Inclusion Criteria:

  • Patients participating in the DCV NPP from 7 European countries (Austria, Denmark, Italy, Sweden, Spain, Switzerland, and UK). The following patients were eligible to participate in the NPP

    • The patient have a serious or life-threatening condition that is impacting life expectancy within 12 months.
    • There are no comparable or satisfactory alternative treatments options exist for the patient, and/or currently available treatment options have been exhausted.
    • The patient was ineligible to participate in a clinical trial, or there was no ongoing clinical trial in the patient´s country of residence to treat his/her HCV-infection.
  • In countries where DCV is commercially available at time of study initiation(Sweden, UK, and Germany), patients treated with DCV during the early post-marketing authorization period.
  • Patients initiating any DCV-based regimen during the inclusion periods.
  • Recorded in one of the HCV data sources used for the study.

Exclusion Criteria:

  • Patients included in the DCV Compassionate use program (CUP) (AI444-237 Protocol) open in 6 European countries (Germany, Austria, Sweden, Netherlands, Norway and UK) after Committee for Medicinal Products for Human Use (CHMP) opinion for the DCV CUP in Europe will be excluded since these patients will be analyzed as part of separate datasets.

Studieplan

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

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Patients treated with DCV (NPP)+Sofosbuvir +/- Ribavirin (RBV)
Patients treated with DCV (NPP) + Simeprevir +/- RBV
Patients treated with DCV(post-marketing) + Sofosbuvir +/- RBV
Patients treated with DCV(post-marketing) + Simeprevir +/- RBV

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SVR12
Tidsram: Up to 36 months
Effectiveness of DCV-based regimens as measured by the SVR12, overall and in specific patient sub-populations
Up to 36 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SVR4
Tidsram: Up to 36 months
Effectiveness of DCV-based regimens as measured by SVR4
Up to 36 months
SVR24
Tidsram: Up to 36 months
Effectiveness of DCV-based regimens as measured by SVR24
Up to 36 months
On-treatment Virological response at week 4 assessed by measuring viral load
Tidsram: Up to 36 months
Up to 36 months
Virological response at the end of treatment (EOT) assessed by measuring viral load
Tidsram: Up to 36 months
Up to 36 months
The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load
Tidsram: Up to 36 months

Virological failure is defined as virologic breakthrough, other on-treatment failure or relapse, where:

  • Virologic breakthrough is defined as confirmed ≥ 1 log10 IU/mL HCV RNA on treatment increase from nadir, or confirmed increase in HCV RNA ≥ LLOQ if HCV RNA previously declined to < LLOQ (TD/TND). (LLOQ: Lower limit of quantification)
  • Relapse is defined as HCV RNA < LLOQ (TND) at End of Treatment followed by confirmed detectable HCV RNA ≥ LLOQ in any follow-up visit window.
  • On-treatment failure is defined as HCV RNA ≥ LLOQ at any time point not meeting the definition of virologic breakthrough or relapse.
Up to 36 months

Samarbetspartners och utredare

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

Sponsor

Bristol-Myers Squibb

Samarbetspartners

Basel Institute of Clinical Epidemiology (BICE)

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.

Användbara länkar

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 mars 2015

Primärt slutförande (Faktisk)

1 februari 2016

Avslutad studie (Faktisk)

1 februari 2016

Studieregistreringsdatum

Först inskickad

11 augusti 2015

Först inskickad som uppfyllde QC-kriterierna

21 augusti 2015

Första postat (Uppskatta)

24 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 maj 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 maj 2016

Senast verifierad

1 maj 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AI444-319

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 .

Prenumerera