- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246894
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
February 14, 2018 updated by: Bio Products Laboratory
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Krakow, Poland, 30-663
- Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
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Poznan, Poland, 61-825
- Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
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Warsaw, Poland, 00-576
- Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
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Wroclaw, Poland, 50-345
- Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.
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Lublin
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W. Chodzki Str., Lublin, Poland, 20-093
- Children's Haematology and Oncology Clinic, Ul.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Optivate®
Optivate® (Human Coagulation Factor VIII)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consumption of FVIII
Time Frame: Day 0 to Week 26
|
Day 0 to Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
September 2, 2014
First Submitted That Met QC Criteria
September 19, 2014
First Posted (Estimate)
September 23, 2014
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8VWF05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Haemophilia A
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Novo Nordisk A/SCompletedHaemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BFrance, United States, India, Mexico, United Kingdom, Netherlands, Sweden, Korea, Republic of, Spain, Switzerland, Serbia, Turkey, Bulgaria, Italy, Japan, Poland, South Africa, Croatia, Algeria, Australia, Bosnia and Herzegovina, ... and more
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Novo Nordisk A/SCompletedEpidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries (HAEMOcare)Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BIndia, Morocco, South Africa, Oman
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BSpain
-
Novo Nordisk A/SRecruitingHaemophilia A With Inhibitors | Haemophilia AUnited States, Korea, Republic of, France, Spain, Romania, Canada, Taiwan, China, Lithuania, Netherlands, India, South Africa, Russian Federation, Austria, Belgium, Czechia, Denmark, Germany, Ireland, Italy, Japan, Latvia, Malaysia, M... and more
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American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
-
Novo Nordisk A/SWithdrawnHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia B
-
Novo Nordisk A/SRecruitingHaemophilia A With Inhibitors | Haemophilia ATaiwan, Canada, Spain, Netherlands, Korea, Republic of, India, United States, United Kingdom, Portugal, Lithuania, Turkey, China, South Africa, Ireland, Italy, France, Japan, Poland, Belgium, Germany, Malaysia, Austria, Bulgaria, Denmark and more
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Novo Nordisk A/SActive, not recruitingHaemophilia A With Inhibitors | Haemophilia ASpain, Korea, Republic of, Canada, United Kingdom, United States, Germany, South Africa, Italy, Austria, Belgium, France, Japan
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia B | Relatives to/Carers of PatientsSpain, Canada, United Kingdom
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Haemophilia A | Haemophilia BUnited States
Clinical Trials on Optivate® (Human Coagulation Factor VIII)
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Bio Products LaboratoryCompletedvonWillebrand's DiseaseIsrael
-
Bio Products LaboratoryCompletedVon Willebrand DiseasePoland, United Kingdom
-
Bio Products LaboratoryCompletedHaemophilia APoland, United Kingdom
-
Bio Products LaboratoryCompletedHaemophilia AUnited Kingdom, Poland
-
CSL BehringParexelCompletedVon Willebrand DiseaseBulgaria, Poland, Russian Federation, Ukraine
-
CSL BehringParexelCompletedHemophilia ABulgaria, Poland, Russian Federation, Macedonia, The Former Yugoslav Republic of
-
OctapharmaTerminated
-
CSL BehringCompletedBlood Coagulation Disorders | Blood Platelet Disorders | Hematologic Disease | Von Willebrand DiseaseUnited States
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Unknown