A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

CompletadoFase 3ClinicalTrials.gov

ID: NCT00627926Tipo: INTERVENTIONALInicio: 1 de mar de 2008Fin estimado: 1 de may de 2010

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
Male and female subjects, 18 to 70 years of age, inclusive
Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Screening laboratory values, tests, and physical exam within acceptable ranges
Able and willing to follow contraception requirements
Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions

Criterios de exclusión

Subject has any contraindications to Pegasys® or Copegus® therapy
Evidence of hepatic decompensation in cirrhotic subjects
History of organ transplant
History of, or any current medical condition which could impact the safety of the subject in participation in the study

Intervenciones

biological

Pegylated Interferon Alfa 2a

subcutaneous injection, 180 micrograms once per week

drug

Telaprevir

375 mg tablets administered orally every 8 hours at a dose of 750 mg

drug

Ribavirin

200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg

other

Placebo

Telaprevir matching placebo

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalVertex Pharmaceuticals Incorporated

ColaboradorTibotec Pharmaceutical Limited

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