Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
NCT ID: NCT01775618
Last Updated: 2020-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2013-05-29
2020-02-19
Brief Summary
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In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being evaluated in 50 male subjects, \< 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary.
Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Main study
Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25-60 international units/kilogram (IU/kg) twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an intravenous (IV) infusion as per clinical needs of each subject up to at least 50 exposure days (EDs) and a minimum of at least 6 months.
BAY94-9027
Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months
Part 2 (Expansion group)
Participants were administered with BAY94-9027 at a dose of 25-60 IU/kg twice per week for prophylaxis for 12 weeks.
BAY94-9027
Twice per week prophylaxis: 25-60 IU/kg, intravenous infusion, for 12 weeks
Extension study
Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25- 60 IU/kg twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an IV infusion as per clinical needs of each subject for at least 50 EDs or until marketing authorization of the drug.
BAY94-9027
Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 additional EDs to achieve at least 100 cumulative EDs, or until marketing authorization of the drug
Interventions
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BAY94-9027
Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months
BAY94-9027
Twice per week prophylaxis: 25-60 IU/kg, intravenous infusion, for 12 weeks
BAY94-9027
Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 additional EDs to achieve at least 100 cumulative EDs, or until marketing authorization of the drug
Eligibility Criteria
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Inclusion Criteria
* Subjects with severe hemophilia A
* Previously treated with FVIII for \> 50 exposure days
Exclusion Criteria
* Any other inherited or acquired bleeding disorder
* Platelet counts \< 100,000/mm\^3
* Creatinine \> 2x the upper limit of normal
* Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \> 5x the upper limit of normal
12 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Sacramento, California, United States
Pensacola, Florida, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Salt Lake City, Utah, United States
La Plata, Buenos Aires, Argentina
Vienna, , Austria
Ghent, , Belgium
Leuven, , Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Thessaloniki, , Greece
Ramat Gan, , Israel
Milan, Lombardy, Italy
Palermo, Sicily, Italy
Padua, Veneto, Italy
Vilnius, , Lithuania
Amsterdam, , Netherlands
Utrecht, , Netherlands
Christchurch, , New Zealand
Hamilton, , New Zealand
Oslo, , Norway
Lodz, , Poland
Olsztyn, , Poland
Bucharest, , Romania
Bucharest, , Romania
Timișoara, , Romania
Esplugues de Llobregat, Barcelona, Spain
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Bristol, , United Kingdom
Manchester, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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Mancuso ME, Biss T, Fischer K, Maas Enriquez M, Steele M, Wang M, Tseneklidou-Stoeter D, Ahuja S, Kenet G. PROTECT VIII kids extension study: Long-term safety and efficacy of BAY 94-9027 (damoctocog alfa pegol) in children with severe haemophilia A. Haemophilia. 2021 May;27(3):434-444. doi: 10.1111/hae.14294. Epub 2021 Mar 16.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Click here to find results for studies related to Bayer products.
Other Identifiers
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2012-004434-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15912
Identifier Type: -
Identifier Source: org_study_id
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