A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

CompletadoClinicalTrials.gov

ID: NCT01492504Tipo: OBSERVATIONALInicio: 7 de feb de 2012Fin estimado: 19 de mar de 2018

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed Written Informed Consent
Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
Completed the required post-treatment follow-up period in previous study
Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
Men and women, ages 18 and older

Criterios de exclusión

Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
Subject must not be participating in any other trial, excluding non-interventional trials
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Intervenciones

drug

Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\]

Ubicaciones

Fundacion Cidea De Paraguay

Ciudad de Buenos Aires, Buenos Aires, Argentina

Centro Oncologico Integral

Mar del Plata, Buenos Aires, Argentina

Hospital Austral

Prov. Buenos Aires, Buenos Aires, Argentina

Instituto Centralizado De Asistencia E Investigacion Clinica

Prov de Santa Fe, Santa Fe Province, Argentina

Local Institution

Buenos Aires, Argentina

Hospital Italiano De Buenos Aires

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Long-Term Follow-up Study of Subjects Who Participated ... | EligiMed