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ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632) (ATHENAS)

4 juin 2015 mis à jour par: Merck Sharp & Dohme LLC

ATHENAS - Retrospective Analysis of Compliance to Treatment of Chronic Hepatitis C With Pegylated Interferon Alpha 2b Associated to Ribavirin Until Week 12 and Correlation With Virological Response in Brazil Health Centers

This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Type d'étude

Observationnel

Inscription (Réel)

902

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

Patients with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Patients will come from approximately 65 Brazilian sites and should satisfy all inclusion criteria and none of the exclusion criteria.

La description

Inclusion Criteria:

  • Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC).
  • Adult patients who are 18 years old or above.
  • Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records.
  • Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
  • Patients who started treatment for chronic hepatitis C from the year 2008 or later.

Exclusion Criteria:

  • Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form.
  • Did not start the treatment with peginterferon alfa-2b and ribavirin.
  • Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.

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

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Group 1: Naïve patients
Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b.
Biologique: Peginterferon alfa-2b
PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 54031
Médicament: Ribavirin
Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 18908
Group 2: Re-treatment
Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C.
Biologique: Peginterferon alfa-2b
PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 54031
Médicament: Ribavirin
Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 18908
Group 3: HIV/HCV co-infected patients
Patients, from Brazil, with confirmed chronic hepatitis C and infected with Humman Immunodeficiency Virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
Biologique: Peginterferon alfa-2b
PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 54031
Médicament: Ribavirin
Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
Autres noms:
  • SCH 18908

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
Délai: First 12 weeks of treatment
The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
First 12 weeks of treatment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent of Participants Who Achieved Rapid Virologic Response (RVR)
Délai: Week 4
RVR was defined as HCV RNA negative after 4 weeks of treatment.
Week 4
Percent of Participants Who Achieved Early Virologic Response (EVR)
Délai: Week 12
EVR was defined as HCV RNA negative after 12 weeks of treatment.
Week 12

Collaborateurs et enquêteurs

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

Parrainer

Merck Sharp & Dohme LLC

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 juillet 2008

Achèvement primaire (Réel)

1 octobre 2010

Achèvement de l'étude (Réel)

1 octobre 2010

Dates d'inscription aux études

Première soumission

4 mars 2009

Première soumission répondant aux critères de contrôle qualité

4 mars 2009

Première publication (Estimation)

5 mars 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 juillet 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2015

Dernière vérification

1 juin 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P05632
  • BR 002-07

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Hépatite C chronique

Essais cliniques sur Peginterferon alfa-2b

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