Human-cl rhFVIII treatment patients with Severe Haemophillia A Ext 01
Research type
Research Study
Full title
Extension Study for Patients who completed GENA-05 (NuProtect) – to Investigate Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII
IRAS ID
141253
Contact name
Raina J Liesner
Contact email
Sponsor organisation
Octapharma Pharmazeutika Produktionsges m.B.H
Eudract number
2013-003997-28
ISRCTN Number
N/A
Research summary
This study is designed as a prospective, multicentre, multinational, (approximately 20-30 centres worldwide) open label, non controlled phase IIIb study. This study is only designed for patients who completed GENA-05 in accordance with the study protocol.
For each patient the exposure and the effect (efficacy) of Human cl rhFVIII in the prevention and treatment of bleeds, the frequency of break through bleeds in the case of prophylactic treatment and the tolerability and safety of Human cl rhFVIII will be thoroughly assessed.
Screening Visit,6 Monthly Follow up Visits, Surgical Visits and Completion Visit will be performed. In the course of the follow up visits patients’ body weight will be checked, and blood samples will be obtained for FVIII inhibitor screen (after a wash-out period of at least 2, preferably 3 days after the previous IMP administration) and for the safety panel. Vital signs will be checked and a physical examination will be performed.
The occurrence of AEs and changes in concomitant medication will be checked and documented. For each patient, the study will be completed once the IMP is registered and launched in the respective country, but no later than 2 years from the screening visit.
At each visit, the patient diary will be reviewed and data transferred into the CRF.
The patient is planned to stay in the study until the IMP is registered and launched in the individual country or for a maximum of 2 years.
The study is planned to start in the 1st quarter of 2014 and continues until the 1st quarter of 2016.
Screening Visits, 6-monthly Follow up Visits, and Completion Visit will be performed.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0406
Date of REC Opinion
10 Dec 2013
REC opinion
Favourable Opinion