An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Sponsor
Bio Products Laboratory (Other)
Overall Status
Completed
CT.gov ID
NCT02250482
Collaborator
(none)
8
1
Study Details
Study Description
Brief Summary
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.
| 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 Haemophilia A Patients Undergoing Surgery.
Study Start Date
:
Nov 1, 2001
Actual Primary Completion Date
:
Aug 1, 2003
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 for plasma Factor VIII [90 minutes after pre-operative bolus dose]
Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinika Haematologii, Akademia Medyczna w Gdansku, ul. | Debinki 7, 80-211 Gdansk | Poland | ||
| 2 | Klinika Haematologii, Akademia Medyczna w Lublinie, ul. | Dr K Jaczewskiego 8, 20-090, Lublin | Poland | ||
| 3 | Klinika Haematologii, Akademia Medyczna w Poznaniu, ul. | Szkolna 8/12, 61-833 Poznan | Poland | ||
| 4 | Haemophilia Centre, Addenbrooke's Hospital, Hills Road | Cambridge | United Kingdom | CB2 2QQ | |
| 5 | Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary | Manchester | United Kingdom | M13 9WL | |
| 6 | Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard | Nottingham | United Kingdom | N67 2UH | |
| 7 | Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road | Sheffield | United Kingdom | S10 2JF | |
| 8 | 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:
NCT02250482
Other Study ID Numbers:
- 8VWF02
First Posted:
Sep 26, 2014
Last Update Posted:
Feb 15, 2018
Last Verified:
Feb 1, 2018