A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01718158Tipo: INTERVENTIONALInicio: 1 de ene de 2013Fin estimado: 1 de oct de 2014

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients chronically infected with HCV Genotype-1b
Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
HCV RNA viral load ≥100,000 IU/mL at screening
Patients with compensated cirrhosis are permitted

Criterios de exclusión

Infection with Hepatitis C virus (HCV) other than Genotype-1b
Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
Evidence of chronic liver disease caused by diseases other than chronic HCV infection
Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Laboratory values:
Hemoglobin \<12.0 g/dL (males) or \<11.0 g/dL (females)
Platelets \<90,000/mm3
Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)

Intervenciones

biological

Peginterferon Lambda-1a

biological

Peginterferon Alfa-2a

drug

Ribavirin

drug

Daclatasvir

drug

Telaprevir

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Prov de Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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