Status:
COMPLETED
Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia
Lead Sponsor:
Catalyst Biosciences
Conditions:
Hemophilia A
Hemophilia B
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subj...
Detailed Description
This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subj...
Eligibility Criteria
Inclusion
- Moderate or severe congenital Hemophilia A or B, with or without an inhibitor
- Male, age 18 or older
- Affirmation of informed consent with signature confirmation before any trial related activities
Exclusion
- Inability to discontinue and washout prophylaxis treatment 72 hours prior to dosing.
- Previous participation in a trial involving SC Administration of rFVIIa or any trial using a modified amino-acid sequence FVIIa
- Known positive antibody to FVII or FVIIa detected by central laboratory at screening
- Have a coagulation disorder other than hemophilia A or B, with or without an inhibitor
- Significant contraindication to participate
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04072237
Start Date
September 24 2019
End Date
June 17 2020
Last Update
September 13 2021
Active Locations (5)
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1
Medical Center "Hippocrates - N"
Plovdiv, Bulgaria
2
Specialized Hospital for Active Treatment of Hematological Diseases
Sofia, Bulgaria
3
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, Russia
4
National Medical Hematology Research Center
Moscow, Russia