Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders
NCT ID: NCT04548791
Last Updated: 2021-12-21
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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TERMINATED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2021-05-17
2021-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 10 μg/kg, 20 μg/kg, 30 μg/kg, 40 μg/kg, and 60 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 20 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Coagulation Factor VIIa variant
Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes
Cohort 2
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 30 μg/kg, 45 μg/kg, 60 μg/kg, 120 μg/kg, and 180 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 60 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Coagulation Factor VIIa variant
Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes
Cohort 3
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 30 μg/kg, 45 μg/kg, 60 μg/kg, 120 μg/kg, and 180 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 60 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Coagulation Factor VIIa variant
Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes
Interventions
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Coagulation Factor VIIa variant
Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes
Other Intervention Names
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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
* Agreement to use highly effective birth control throughout the study if the subject has childbearing potential
Exclusion Criteria
* Previous participation in a clinical trial evaluating a modified rFVIIa agent
* Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect, whichever is longer
* Known hypersensitivity to trial or related product
* Known positive antibody to FVII or FVIIa detected by central lab at screening
* 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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UC Davis Medical Center
Sacramento, California, United States
University of California -San Francisco
San Francisco, California, United States
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, United States
Rush University
Chicago, Illinois, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Michigan State University Center for Bleeding Disorders & Clotting Disorders
East Lansing, Michigan, United States
East Carolina University
Greenville, North Carolina, United States
Mazumdar Shaw Medical Centre
Bengaluru, , India
St. John's Medical College Hospital
Bengaluru, , India
Amrita Institute of Medical Sciences and Research Centre
Kochi, , India
K. J. Somaiya Hospital and Research Centre
Mumbai, , India
Sahyadri Super Speciality Hospital
Pune, , India
Careggi University Hospital
Florence, , Italy
Center for Thrombosis and Haemorrhagic Diseases
Milan, , Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milan, , Italy
Children's Hospital BambiNo Gesù, IRCCS (PEDS)
Roma, , Italy
City of Health and Science of Turin
Turin, , Italy
Territorial Clinical Hospital
Barnaul, , Russia
National Medical Hematology Research Center under the Ministry of Healthcare of the Russian Federation
Moscow, , Russia
Institute of Blood Pathology and Transfusion Medicine, Department of Surgery and Clinical Transfusiology
Lviv, , Ukraine
Countries
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Other Identifiers
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MAA-202
Identifier Type: -
Identifier Source: org_study_id