A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection

CompletadoFase 2ClinicalTrials.gov

ID: NCT00911963Tipo: INTERVENTIONALInicio: 1 de abr de 2009Fin estimado: 1 de sept de 2012

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin. The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)
Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)
Plasma HCV RNA of 100,000 IU/ml
HIV 1 and HIV2 ab seronegative
Body Mass Index (BMI) ≤ 35 kg/m2 BMI
Treatment Naive subjects

Criterios de exclusión

Contraindications to peginterferon or ribavirin therapy
Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score \> 5
Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes

Intervenciones

drug

VCH-222 or matching placebo

capsule, oral, 4 doses once daily or twice daily, 3 days

drug

VCH-222 or matching placebo

capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks

biological

peginterferon alfa-2a

subcutaneous injection, 180 μg, once weekly, 48 weeks

drug

ribavirin

tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks

Ubicaciones

ACLIRES Argentina SRL

Buenos Aires, Argentina

Hospital Universitario Austral

Buenos Aires, Argentina

Patrocinadores

PrincipalVertex Pharmaceuticals Incorporated

ColaboradorViroChem Pharma

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