EICHORCondition: Hemophilia A With Inhibitor · Hemophilia B With Inhibitor · Sponsor: Catalyst Biosciences
Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \[SC\] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Severe congenital hemophilia A or B with an inhibitor. * History of frequent spontaneous bleeding episodes. * Male, age 18 or older. * Affirmation of informed consent with signature confirmation before any trial-related activities. Exclusion Criteria: * Receiving prophylaxis treatment. * Previous participation in a clinical trial evaluating a modified rFVIIa agent. * Known positive antibody to FVII or FVIIa detected by central laboratory at screening. * Have a coagulation disorder other than hemophilia A or B. * Significant contraindication to participation.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hematology Center after Prof. R. Yeolyan | Yerevan, Armenia | — |
| JSC "K.Eristavi National Center of Experimental and Clinical Surgery" | Tbilisi, Georgia | — |
| LTD M.Zodelava Hematology Centre | Tbilisi, Georgia | — |
| LTD Medinvest - Institute of Hematology and Transfusiology | Tbilisi, Georgia | — |
| Gabinet Lekarski, Bartosz Korczowski | Rzeszów, Poland | — |
| Regional Clinical Hospital | Kemerovo, Russia | — |
| FGU Kirov Scientific Research | Kirov, Russia | — |
| Center for Hemophilia Treatment | Saint Petersburg, Russia | — |
| Haemophilia Comprehensive Care Centre | Johannesburg, South Africa | — |
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Source record: clinicaltrials.gov/study/NCT03407651