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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 mai 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Hépatite C

Type d'étude

Observationnel

Inscription (Réel)

249

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Suisse
- - Basel, Suisse
    - Local Institution

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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)

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
SVR12 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
SVR4 Délai: Up to 36 months	Effectiveness of DCV-based regimens as measured by SVR4	Up to 36 months
SVR24 Délai: 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 Délai: Up to 36 months		Up to 36 months
Virological response at the end of treatment (EOT) assessed by measuring viral load Délai: Up to 36 months		Up to 36 months
The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Collaborateurs

Basel Institute of Clinical Epidemiology (BICE)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

BMS clinical trial educational resource

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2015

Achèvement primaire (Réel)

1 février 2016

Achèvement de l'étude (Réel)

1 février 2016

Dates d'inscription aux études

Première soumission

11 août 2015

Première soumission répondant aux critères de contrôle qualité

21 août 2015

Première publication (Estimation)

24 août 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

9 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

AI444-319

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