Back to resultsA Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Primary Purpose
Haemophilia A
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Optivate® (Human Coagulation Factor VIII)
Sponsored by
About this trial
This is an interventional trial for Haemophilia A
Eligibility Criteria
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:
-
Sites / Locations
- Children's Haematology and Oncology Clinic, Ul.
- Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
- Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
- Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
- Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optivate®
Arm Description
Optivate® (Human Coagulation Factor VIII)
Outcomes
Primary Outcome Measures
Consumption of FVIII
Secondary Outcome Measures
Full Information
NCT ID
NCT02246894
First Posted
September 2, 2014
Last Updated
February 14, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02246894
Brief Title
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia A
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Optivate®
Arm Type
Experimental
Arm Description
Optivate® (Human Coagulation Factor VIII)
Intervention Type
Biological
Intervention Name(s)
Optivate® (Human Coagulation Factor VIII)
Primary Outcome Measure Information:
Title
Consumption of FVIII
Time Frame
Day 0 to Week 26
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Children's Haematology and Oncology Clinic, Ul.
City
W. Chodzki Str.
State/Province
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
City
Poznan
ZIP/Postal Code
61-825
Country
Poland
Facility Name
Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
City
Warsaw
ZIP/Postal Code
00-576
Country
Poland
Facility Name
Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
We'll reach out to this number within 24 hrs