Von Willebrand Disease Clinical Trial
Official title:
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
| NCT number | NCT02246881 |
| Other study ID # | 8VWFPK |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | February 14, 2018 |
| Start date | October 2001 |
| Verified date | February 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | January 2004 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days. Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Klinika Haematologii, Akademia Medyczna w Gdansku, ul. | Debinki 7, 80-211 Gdansk | |
| Poland | Klinika Haematologii, Akademia Medyczna w Lublinie, ul. | Dr K Jaczewskiego 8, 20-090, Lublin | |
| Poland | Klinika Haematologii, Akademia Medyczna w Lodzi, ul. | Pabianicka 62, 93-513 Lodz | |
| United Kingdom | Haemophilia Centre, University Hospital, Queens Medical Centre | Clifton Boulevard, Nottingham | |
| United Kingdom | Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital | Glossop Road, Sheffield | |
| United Kingdom | Haemophilia Centre, Addenbrooke's Hospital | Hills Road, Cambridge | Cambridgeshire |
| United Kingdom | Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary | Manchester | |
| United Kingdom | Haemophilia Centre, Southampton General Hospital | Tremona Road, Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PK parameters for FVIII:C | Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose |
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