PB102F03: Extension Study of PRX-102 in Fabry Disease
Research type
Research Study
Full title
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry Patients.
IRAS ID
184835
Contact name
Einat Brill Almon
Contact email
Sponsor organisation
Protalix Ltd.
Eudract number
2014-005544-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
The PB-102-F03 trial is the second extension of the PB-102-F01 trial. The PB-102-03 trial is a worldwide, multi-center, open label study to evaluate the safety, tolerability and exploratory efficacy parameters of PRX-102 in adult Fabry patients. PRX-102 is a chemically modified human enzyme (alpha galactosidase) produced in plant cells and implied for long-term enzyme replacement therapy in patients with Fabry disease. The trial consists of 16 adult Fabry patients (9 male and 7 female), each in one of three dosing groups, 0.2 mg/kg, 1mg/kg and 2mg/kg. Each patient will receive the same dose of PRX-102 they received in the PB-102-F02 study, as an inrtavenous infusion every two weeks for 24 months.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1585
Date of REC Opinion
16 Sep 2015
REC opinion
Favourable Opinion