A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
NCT ID: NCT02448680
Last Updated: 2022-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2015-12-07
2017-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Coagulation Factor VIIa (Recombinant): 75 µg/kg
75 µg/kg treatment regimen for 3 months
Coagulation FVIIa (Recombinant)
A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Coagulation Factor VIIa (Recombinant): 225 µg/kg
225 µg/kg treatment regimen for 3 months
Coagulation FVIIa (Recombinant)
A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Interventions
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Coagulation FVIIa (Recombinant)
A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Eligibility Criteria
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Inclusion Criteria
* have one of the following:
* a positive inhibitor test BU ≥5, OR
* a Bethesda Unit (BU) \<5 but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the patient's medical history, precluding the use of factor VIII or IX products to treat bleeding episodes, OR
* a BU \<5 but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the patient's medical history, precluding the use of factor VIII or IX products to treat bleeding episodes
* be aged from birth to \<12 years old
* have experienced at least 3 bleeding episodes of any severity in the past 6 months
* parents or legal guardians must be capable of understanding and be willing to comply with the conditions of the protocol
* parents or legal guardians must have read, understood, and provided written informed consent
Exclusion Criteria
* be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive medication; cluster of differentiation 4 (CD4) counts at screening must be \>200/µL)
* have a known allergy or hypersensitivity to rabbits
* have platelet count \<100,000/mL
* have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior to first administration of study drug
* have received an investigational drug within 30 days of first study drug administration, or be expected to receive such drug during participation in this study
11 Years
MALE
No
Sponsors
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LFB USA, Inc.
INDUSTRY
Laboratoire français de Fractionnement et de Biotechnologies
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver Hemophilia & Thrombosis Center
Aurora, Colorado, United States
Jimmy Everest Center for Cancer and Bleeding Disorders
Oklahoma City, Oklahoma, United States
UT Southwestern Medical Center at Dallas / Children's Medical Center
Dallas, Texas, United States
University Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv, , Bulgaria
University Hospital Motol
Prague, , Czechia
Hematology of Department Hemophilia and Thromboses center
Tbilisi, , Georgia
Worthwhile Clinical Trials
Benoni, , South Africa
National Specialized Children's Hospital OKHMATDYT, Centre for Hemostatic Pathology (Ukraine)
Kyiv, , Ukraine
Institute of Blood Pathology and Transfusion Medicine
Lviv, , Ukraine
Countries
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References
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Young G, Mahlangu J, Boggio LN, Carcao M, Dargaud Y, Escobar M, Giermasz A, Hermans C, Kuriakose P, Miesbach W, Nance D, Rafique A, Sidonio RF Jr, Vilchevska KV, Wang M, Pipe SW. Treatment of severe bleeds with eptacog beta in hemophilia A or B with inhibitors: a post hoc analysis of the PERSEPT 1 and 2 trials. Blood Vessel Thromb Hemost. 2025 Mar 27;2(3):100069. doi: 10.1016/j.bvth.2025.100069. eCollection 2025 Aug.
Carcao M, Hermans C, Giermasz A, Kessler C, Miesbach W, Quon D, Windyga J, Mahlangu J. Safety and Use of Eptacog Beta 225 microg/kg in Patients With Haemophilia A or B With Inhibitors. Haemophilia. 2025 Sep;31(5):957-965. doi: 10.1111/hae.70083. Epub 2025 Jul 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Final Version 2.0
Document Type: Statistical Analysis Plan: Statistical Analysis Plan (v2.0) Addendum
Other Identifiers
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LFB-FVIIa-007-14
Identifier Type: -
Identifier Source: org_study_id
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