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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
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

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
Haemophilia A Biological: Optivate® (Human Coagulation Factor VIII) Phase 3

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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


Arm Intervention/treatment
Experimental: Optivate®
Optivate® (Human Coagulation Factor VIII)
Biological: Optivate® (Human Coagulation Factor VIII)



Primary Outcome Measures :
  1. Consumption of FVIII [ Time Frame: Day 0 to Week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

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


Locations
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Poland
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
Sponsors and Collaborators
Bio Products Laboratory

Additional Information:
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02246894    
Other Study ID Numbers: 8VWF05
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants