Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

21 novembre 2018 mis à jour par: Hoffmann-La Roche

Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Aperçu de l'étude

Statut

Complété

Les conditions

Hépatite C chronique

Type d'étude

Observationnel

Inscription (Réel)

991

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

Israël
- - Afula, Israël, 18101
    - Haemek Hospital; Gastroenterology
  - Ashkelon, Israël, 78278
    - Barzilai MC; Gastroenterology
  - Beer Sheva, Israël, 84105
    - Soroka Medical Center; Gastroenterology
  - Hadera, Israël, 38100
    - Hillel Yaffe Hospital; Gastroenterology
  - Haifa, Israël, 31096
    - Rambam Medical Center; Gastroenterology - Liver Unit
  - Haifa, Israël, 33394
    - Bnei-Zion Medical Center; Gastroenterology
  - Haifa, Israël, 34362
    - Carmel Hospital; Liver Unit
  - Holon, Israël, 58100
    - Wolfson Hospital; Gastroenterology Unit
  - Jerusalem, Israël, 91031
    - Shaare Zedek Hospital Liver Unit; Liver Unit
  - Jerusalem, Israël, 91120
    - Hadassah Hospital; Liver Unit
  - Kfar Saba, Israël, 44281
    - Meir Medical Center; Liver Unit
  - Nahariya, Israël, 22100
    - Western Galilee Hospital - Nahariya
  - Nazareth, Israël
    - Holy Family Medical Center; Liver Unit
  - Petach Tikva, Israël
    - Hasharon Mc; Gastroenterology
  - Petah Tiqwa, Israël
    - Beilinson-Rabin Liver Unit; Liver Unit
  - Ramat Gan, Israël, 5262100
    - Sheba Medical Center; Tel Hashomer
  - Rehovot, Israël, 76100
    - Kaplan Medical Center; Gastroenterology Unit
  - Safed, Israël, 13110
    - Rebecca Sieff Medical Center; Liver Unit
  - Tel Aviv, Israël, 6423906
    - Tel-Aviv Sourasky Medical Center; Liver Unit
  - Tiberias, Israël
    - Poria Hospital; Gastroenterology
  - Zerifin, Israël, 6093000
    - Assaf Harofeh; Gastroenterology

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 de probabilité

Population étudiée

Chronic hepatitis C patients initiating Pegasys-based treatment

La description

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

Hepatitis A/B co-infection
Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Pregnant or breast-feeding women

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

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Cohorte

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants With Sustained Viral Response (SVR) at Week 24 Délai: Week 24	The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.	Week 24

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Comparison of SVR at Week 24 Délai: Week 24	SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.	Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics Délai: Week 24	The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.	Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 Délai: Week 4	RVR was defined as HCV-RNA <50 IU/mL by Week 4	Week 4
Percentage of Participants With Extended RVR Délai: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group	Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.	Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR) Délai: Week 12	Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12	Week 12
Percentage of Participants With End of Treatment Response (EoT) Délai: Week 24	End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.	Week 24
Percentage of Participants With Virologic Relapse Délai: Week 72	Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.	Week 72
Treatment Duration Délai: Week 48	The average amount of time a treatment was prescribed to participants.	Week 48
Time to First Dose Modification of Peginterferon Alfa-2a Délai: Week 48		Week 48
Time to First Dose Modification of Ribavirin Délai: Week 48		Week 48
Time to First Dose Modification of Telaprevir/Boceprevir Délai: Week 48		Week 48
Percentage of Participants With Adverse Events (AEs) Délai: Week 48	Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.	Week 48
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia Délai: Week 48		Week 48
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Délai: Week 48		Week 48
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications Délai: Week 24	Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.	Week 24

Collaborateurs et enquêteurs

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

Parrainer

Hoffmann-La Roche

Collaborateurs

Clalit Health Services

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 (Réel)

28 mai 2012

Achèvement primaire (Réel)

10 février 2016

Achèvement de l'étude (Réel)

10 février 2016

Dates d'inscription aux études

Première soumission

21 mai 2012

Première soumission répondant aux critères de contrôle qualité