To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To provide access to a telaprevir-based treatment to subjects of the Control
Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate
response to treatment . Safety, tolerability, and HCV RNA levels will be
collected.
Secondary outcome
not applicable
Background summary
Despite the significant advances that have been made in the treatment of
chronic hepatitis C virus (HCV) infection in recent years, there is an ongoing
need for effective treatment in patients who fail to achieve sustained
virologic response (SVR). An antiviral drug such as telaprevir that could be
administered in combination with direct or indirect-acting antivirals to
produce a higher rate of viral eradication with a better safety profile and/or
shorter treatment duration is highly desirable.
Study objective
To provide access to a telaprevir-based treatment to subjects of the Control
Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate
response to treatment (according to treatment stopping rules). Safety,
tolerability, and HCV RNA levels will be collected.
Study design
Open-label, single arm study
Intervention
Telaprevir will be administered as an oral tablet. All subjects will receive a
loading dose of 1125 mg telaprevir (3 tablets) as their first dose on Day 1
followed by 750 mg (2 tablets) q8h thereafter. Peg-IFN-*-2a (Pegasys®) will be
dosed at 180 mg weekly by subcutaneous injection. RBV (Copegus®) will be
administered orally, and the dose will be weight-based (1000 mg for subjects
<75 kg or 1200 mg daily for subjects *75 kg).
Study burden and risks
The subject will be treated with study medication for the duration of 24 weeks
During the treatment period will the subjects visit the hospital 11 times If
necessary additional visits can be scheduled by the investigator.
Two weeks after the last dose of study medication will the subject visit the
hospital for a follow up visit .
A full physical examiniation will be performed a number of times during the
study. During every visits will blood be drawn.
The subject will be asked to complete a dosing sheet for the study medication.
The subject may experience adverse reactions while taking study medication.
Men and women must use an effective method of contraception as descirbed in the
study protocol.
The use of certain medication is allowed while the subject is participating in
the trial. This medication is described in the study protocol.
130 Waverly Street
Cambridge, Massachusetts 02139-424
Verenigde Staten
130 Waverly Street
Cambridge, Massachusetts 02139-424
Verenigde Staten
Listed location countries
Age
Inclusion criteria
- Subjects randomized in the control arm (Group A) of Study VX06-950-106 are eligible to participate. In addition, these subjects must have discontinued treatment in that study because of the following criteria:
* Week 4 Nonresponder, defined as not having a > or <= 1-log10 decrease from baseline in HCV RNA.
* Viral breakthrough between Week 4 and Week 24. Subjects discontinued study treatment if, on 2 consecutive occasions, the results of HCV RNA testing indicated viral breakthrough. Viral breakthrough is defined as (1) an increase in HCV RNA of >1 log10 compared to the lowest recorded on-treatment value or (2) an HCV RNA level of >100 IU/mL in a subject who had undetectable HCV RNA at a prior time point.
* Week 12 (EVR) Nonresponder, defined as not having achieved an early viral response (EVR, a *2 log10 reduction from baseline in HCV RNA).
* Week 24 Nonresponder, defined as subjects who had detectable HCV RNA at Week 24.
* Week 26 to Week 48 Nonresponder; defined as subjects who had detectable HCV RNA between Weeks 26 and 48.
* Subjects who had detectable HCV RNA during the 24-week post-treatment period.
- Subjects must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the last dose of study drug. Female subjects of childbearing potential must have a negative pregnancy test at all visits prior to the first dose.
- Subjects must be willing to refrain from the concomitant use of any medications, substances or foods noted in Section 18 of the protocol.
- Subjects must be able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions.
- Subjects must agree not to participate in other clinical studies for the duration of their participation in this trial.
Exclusion criteria
- Subjects who discontinued prior Peg-IFN or RBV for adverse events or for any other reason other than failure to respond to therapy and for whom repeated treatment would be inappropriate.
- Women who are pregnant or breast-feeding.
- Male partners of women who are pregnant or breast-feeding.
- Subjects who have taken any of the prohibited medications identified in Section 18 within 30 days of Day 1.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005123-42-NL |
| CCMO | NL16174.018.07 |