Haemophilia A Clinical Trial
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.
NCT number | NCT02246894 |
Other study ID # | 8VWF05 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | September 2, 2014 |
Last updated | February 14, 2018 |
Start date | November 2003 |
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 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Years |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
Poland | Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str. | Krakow | |
Poland | Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str. | Poznan | |
Poland | Children's Haematology and Oncology Clinic, Ul. | W. Chodzki Str. | Lublin |
Poland | Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str. | Warsaw | |
Poland | Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str. | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
Bio Products Laboratory |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consumption of FVIII | Day 0 to Week 26 |
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