Haemophilia A Clinical Trial
Official title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
| Verified date | February 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | August 2004 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover. Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul. | Bialystok | |
| Poland | Klinika Haematologii, Akademia Medyczna w Gdansku, u. | Gdansk | |
| Poland | Klinika Haematologii, Akademia Medyczna w Lodzi, ul. | Lodz | |
| Poland | Klinika Haematologii, Akademia Medyczna w Lublinie, ul. | Lublin | |
| Poland | Klinika Haematologii, Akademia Medyczna w Poznaniu, ul. | Poznan | |
| Poland | Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul. | Wroclaw | |
| United Kingdom | Haemophilia Centre, Addenbrooke's Hospital, Hills Road | Cambridge | |
| United Kingdom | Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary | Manchester | |
| United Kingdom | Haemophilia Centre, University Hospital, Queen's 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 | Comparison of Baseline with 3 months post-baseline |
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