An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Sponsor
Bio Products Laboratory (Other)
Overall Status
Completed
CT.gov ID
NCT02246868
Collaborator
(none)
11
1
Study Details
Study Description
Brief Summary
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®.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Study Start Date
:
Sep 1, 2001
Actual Primary Completion Date
:
Aug 1, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Optivate® Optivate® (Human Coagulation Factor VIII) |
Biological: Optivate® (Human Coagulation Factor VIII)
|
Outcome Measures
Primary Outcome Measures
- Incremental Recovery [Comparison of Baseline with 3 months post-baseline]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul. | Bialystok | Poland | ||
| 2 | Klinika Haematologii, Akademia Medyczna w Gdansku, u. | Gdansk | Poland | ||
| 3 | Klinika Haematologii, Akademia Medyczna w Lodzi, ul. | Lodz | Poland | ||
| 4 | Klinika Haematologii, Akademia Medyczna w Lublinie, ul. | Lublin | Poland | ||
| 5 | Klinika Haematologii, Akademia Medyczna w Poznaniu, ul. | Poznan | Poland | ||
| 6 | Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul. | Wroclaw | Poland | ||
| 7 | Haemophilia Centre, Addenbrooke's Hospital, Hills Road | Cambridge | United Kingdom | CB2 2QQ | |
| 8 | Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary | Manchester | United Kingdom | M13 9WL | |
| 9 | Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard | Nottingham | United Kingdom | NG7 2UH | |
| 10 | Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road | Sheffield | United Kingdom | S10 2JF | |
| 11 | Haemophilia Centre, Southampton General Hospital, Tremona Road | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Bio Products Laboratory
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT02246868
Other Study ID Numbers:
- 8VWFSE
First Posted:
Sep 23, 2014
Last Update Posted:
Feb 15, 2018
Last Verified:
Feb 1, 2018