Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
NCT ID: NCT04489537
Last Updated: 2021-12-17
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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TERMINATED
PHASE3
18 participants
INTERVENTIONAL
2021-05-04
2021-12-01
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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MarzAA
Coagulation Factor VIIa variant, 60 µg/kg by subcutaneous route, administered on-demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis
MarzAA
A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.
Standard of Care
Standard of care administered on-demand during bleeding episodes
MarzAA
A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.
Interventions
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MarzAA
A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.
Eligibility Criteria
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Inclusion Criteria
* Male or Female, age 12 or older
* History of frequent bleeding episodes
* Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
Exclusion Criteria
* Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
* Known hypersensitivity to trial or related product
* Known positive antibody to FVII or FVIIa detected by central lab at screening
* Have a coagulation disorder other than hemophilia A or B
* Be immunosuppressed
* Significant contraindication to participate
12 Years
ALL
No
Sponsors
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Catalyst Biosciences
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Hematology Center after Prof. R. Yeolyan
Yerevan, , Armenia
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, , Georgia
Magyar Honvédség Egészségügyi Központ, Országos Haemophilia Központ
Budapest, , Hungary
Nirmal Hospital
Gujrāt, , India
K.L.E.S Dr. Prabhakar Kore Hospital and Medical Research Centre
Kārnād, , India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, , India
K.J Somaiya Hospital and Research Centre
Mumbai, , India
MCGM - Comprehensive Thalassemia Care, Pediatric Hematology-Oncology & BMT Centre
Mumbai, , India
Sahyadri Specialty Hospital
Mumbai, , India
Grant Medical Foundation, Ruby Hall Clinic
Pune, , India
All India Institute of Medical Sciences, Rishikesh
Rishikesh, , India
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Citta della Salute e della Scienza di Torino - Ospedale le Molinette
Torino, , Italy
Hospital Ampang
Ampang, , Malaysia
Raja Perempuan Zainab II Hospital
Kota Bharu, , Malaysia
Queen Elizabeth Hospital Malaysia
Kota Kinabalu, , Malaysia
Hospital Tunku Azizah Kuala Lumpur
Kuala Lumpur, , Malaysia
Tuanku Ja'afar Hospital, Seremban
Sungai Petani, , Malaysia
Instituto de Investigaciones Aplicada a la Neurociencia A.C.
Durango, , Mexico
Instituto Nacional de Pediatria
Mexico City, , Mexico
Investigación e Innovación en Medicina Traslacional S.A.P.I. de C.V.
Mexico City, , Mexico
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, , Russia
Medis, Llc
Nizhny Novgorod, , Russia
Haemophilia Comprehensive Care Centre
Johannesburg, , South Africa
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de Malaga
Málaga, , Spain
Changhua Christian Hospital (CCH)
Changhua, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Akdeniz University Medical Faculty Hospital
Antalya, , Turkey (Türkiye)
Istanbul University Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Özel Acibadem Adana Hastanesi
Seyhan, , Turkey (Türkiye)
"Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council", Regional Treatment and Diagnostic Center of Hematology
Cherkasy, , Ukraine
"Kyiv City Clinical Hospital #9" of Executive Body of Kyiv City Council (Kyiv City State Administration), City Scientific-Practical Centre of Diagnostics and Treatment
Kyiv, , Ukraine
"Institute of Blood Pathology and Transfusion Medicine of National Academy of Medical Sciences of Ukraine", Haematology Department
Lviv, , Ukraine
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Other Identifiers
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MAA-304
Identifier Type: -
Identifier Source: org_study_id