CompletedPhase 1

Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

Bulgaria, Russia11 participantsStarted 2019-09-24

Plain-language 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 subjects with moderate or severe Hemophilia A or B, with or without an inhibitor.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Comparative MarzAA Activity by Dose Level/Stage - AUC0-∞ and AUC0-last

Timeframe: Dosing period for each stage was approximately 3 days, with a maximum of approximately 8 weeks of dosing, depending on participation in all 9 stages and time elapsed between each study stage.

Comparative MarzAA Activity by Dose Level/Stage - AUCT1-T2 Normalized by Dose = AUC0-last/Dose

Trial details

NCT IDNCT04072237

SponsorCatalyst Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-30

Results submitted2021-04-30

View on ClinicalTrials.gov More Hemophilia A trials