Haemophilia A Clinical Trial
Official title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
| NCT number | NCT02250482 |
| Other study ID # | 8VWF02 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | February 14, 2018 |
| Start date | November 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 investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | August 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate. 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 Poznaniu, ul. | Szkolna 8/12, 61-833 Poznan | |
| United Kingdom | Haemophilia Centre, Addenbrooke's Hospital, Hills Road | Cambridge | |
| United Kingdom | Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary | Manchester | |
| 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, Southampton General Hospital, Tremona Road | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incremental Recovery for plasma Factor VIII | Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG | 90 minutes after pre-operative bolus dose |
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