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A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-1...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-005123-42

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

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Extrait

To provide access to a telaprevir-based treatment to subjects enrolled in the Peg IFN alfa-2a plus ribavirin Control Group (Group A) of Studies VX06 950-106 (Study 106), VX05-950-104 (Study 104) or VX05 950 104EU (Study 104EU) who stopped treatment due to inadequate response to treatment, or who relapsed after treatment. To demonstrate the efficacy of telaprevir in combination with Peg IFN alfa-2a and RBV in treatment-experienced subjects with genotype 1 chronic HCV. To evaluate safety of telaprevir in combination with Peg IFN alfa-2a and RBV in treatment-experienced subjects with genotype 1 chronic HCV.

Critère d'inclusion

  • Hepatitis C virus (HCV) infection

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