VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide access to telaprevir for patients from the control
      group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and
      tolerability of telaprevir in combination with standard treatment will be evaluated.
    

Detailed description: 
      This is an open-label (i.e all people involved know the identity of the intervention),
      single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN)
      alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for
      patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred
      to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy,
      safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be
      evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein
      associated with the hepatitis C virus) protease domain will be evaluated. The trial will
      consist of a screening period of approximately 28 days, a 48-week treatment period, and a
      24-week follow-up period. It is expected that approximately 120 patients could be eligible
      for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have
      discontinued earlier), patients can only enter the current trial upon invitation. The
      investigator will receive an invitation sent by the unblinded independent virology monitor of
      the C216 trial for those patients of the C216 trial who were randomized to the control group
      and who failed therapy for virologic reasons. Next to this invitation, the patient will need
      to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible
      to participate. The screening visit for the current trial can only occur after the patient
      completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients
      must not enter this trial later than 80 weeks after their first dose in the C216 trial. In
      the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours
      (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once
      weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg
      IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL
      undetectable at the end of treatment (Week 48 or having discontinued earlier) will be
      followed for 24 weeks after the last dose of study medication to assess sustained virologic
      response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs),
      regardless of severity, will be collected continuously until the Safety Follow-up Visit,
      scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse
      events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h
      (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram
      once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively,
      followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
    

Intervention name(s): Telaprevir; pegylated interferon (Peg-IFN) alfa-2a; ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750 mg orally every 8 hours (q8h) for 12 weeks; 180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.; 1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Telaprevir; Roll-over study