vx-950-tidp24-c219: a roll over trial for patients in the control group of the c216 study who received telaprevir placebo

Conditions: Hepatitis C, Chronic

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.

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.

Eligibility criteria:
inclusion criteria: * patient from the control group of the c216 study who failed therapy for virologic reasons * patient must have completed all assessments in the c216 trial * patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication exclusion criteria: * patient received any direct acting anti-viral hcv therapy after discontinuation of the c216 trial * patient has history of decompensated liver disease * patient has history of acute or chronic pancreatitis * patient has condition that requires use of systemic corticosteroids * patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment * patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma

Keywords: hepatitis c, chronic telaprevir roll-over study