A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02246894|
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : February 15, 2018
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|
|Haemophilia A||Biological: Optivate® (Human Coagulation Factor VIII)||Phase 3|
|Study Type :||Interventional (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.|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||January 2005|
Optivate® (Human Coagulation Factor VIII)
Biological: Optivate® (Human Coagulation Factor VIII)
- Consumption of FVIII [ Time Frame: Day 0 to Week 26 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246894
|Children's Haematology and Oncology Clinic, Ul.|
|W. Chodzki Str., Lublin, Poland, 20-093|
|Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.|
|Krakow, Poland, 30-663|
|Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.|
|Poznan, Poland, 61-825|
|Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.|
|Warsaw, Poland, 00-576|
|Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.|
|Wroclaw, Poland, 50-345|