A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus

TerminadoFase 3ClinicalTrials.gov

ID: NCT00496158Tipo: INTERVENTIONALInicio: 1 de ago de 2007

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg negative hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
Subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5).
The number of subjects entering the study with an Ishak fibrosis score of 5 will be limited to approximately 10%. If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.

Criterios de exclusión

Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
Subjects with clinically significant concomitant diseases will be excluded.

Intervenciones

drug

Clevudine

drug

Adefovir

Ubicaciones

Centro de Hepatologia

Buenos Aires, Argentina

Funcei

Buenos Aires, Argentina

Fundacion Favaloro

Buenos Aires, Argentina

Hospital Aleman

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Hospital Universitario Austral

Buenos Aires, Argentina

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

Sanatorio Guemes

Buenos Aires, Argentina

Sanatorio Dei Salvador

Córdoba, Argentina

H.I.G.A O. Alende

Mar del Plata, Argentina

Patrocinadores

PrincipalPharmasset

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