A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Sponsor
Bio Products Laboratory (Other)
Overall Status
Completed
CT.gov ID
NCT02246894
Collaborator
(none)
5
1
Study Details
Study Description
Brief Summary
The main objectives of this study are:
-
to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
-
to assess clinical outcome when treating a bleed with Optivate®.
-
to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
-
to assess FVIII inhibitor development during the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Official Title:
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
Study Start Date
:
Nov 1, 2003
Actual Primary Completion Date
:
Jan 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Optivate® Optivate® (Human Coagulation Factor VIII) |
Biological: Optivate® (Human Coagulation Factor VIII)
|
Outcome Measures
Primary Outcome Measures
- Consumption of FVIII [Day 0 to Week 26]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Haematology and Oncology Clinic, Ul. | W. Chodzki Str. | Lublin | Poland | 20-093 |
| 2 | Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str. | Krakow | Poland | 30-663 | |
| 3 | Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str. | Poznan | Poland | 61-825 | |
| 4 | Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str. | Warsaw | Poland | 00-576 | |
| 5 | Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str. | Wroclaw | Poland | 50-345 |
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:
NCT02246894
Other Study ID Numbers:
- 8VWF05
First Posted:
Sep 23, 2014
Last Update Posted:
Feb 15, 2018
Last Verified:
Feb 1, 2018