von Willebrands Disease MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease
Conditions
Interventions
Trade Name: Optivate
Product Code: N/A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Human coagulation factor VIII associated with von Willebrand factor (VWF)
Concentrati
Sponsors
Bio Products Laboratory
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have given written informed consent. 2. Be aged 12 years or older. 3. Have severe VWD (VWF:RCo =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening. 2. Actively bleeding (Note: the patient can enter the study once the bleed is controlled). 3. Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator. 4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients. 5. Have a recent history of alcohol or drug abuse. 6. Administration of a new chemical entity within the 4 months preceding enrolment. 7. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study protocol 8VWF03, in such cases patients should have completed their End-of study visit either before or on the day of screening for this study. 8. In the option of the investigator, the pateint is unlikely to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pharmacokinetics of Optivate;Secondary Objective: Efficacy and Safety of Optivate in long-term use over at least 12 months.;Primary end point(s): AUC (0-t), AUC(0-72h), MRT(0-t) and MRT (0-72h) for VWF:RCo at the Baseline Visit (Visit 1) by VWD type and overall | — |
Countries
Poland, United Kingdom
Outcome results
None listed