At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 11 enrolled
Drug / intervention
MarzAA (marzeptacog alfa [activated])biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Ascending Doses of Subcutaneous Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia
In Brief
A Phase 1 clinical trial evaluating MarzAA (marzeptacog alfa [activated]) for Hemophilia A and 5 related conditions. Completed, enrolled 11 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A, Hemophilia B, Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Hemophilia A Without Inhibitor, Hemophilia B Without Inhibitor
CountriesBulgaria, Russia
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionApr 2020
Study CompletionJun 2020
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartSep 24, 2019
Primary CompletionApr 30, 2020
Study CompletionJun 17, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.8 years ago
Interventions
MarzAA (marzeptacog alfa [activated])biological
Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)