Hemophilia A or B With Inhibitors Clinical Trial
Official title:
A Phase 1,Randomized, Single-blind, Placebo-controlled, Single Dose, Dose-escalated Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Profile of Subcutaneous Administration of a Long-acting Recombinant Factor VIIa in Healthy Adult Males
A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.
This will be a single-dose, randomized, single-blind, placebo-controlled, dose-escalating
study.
The study will include four escalating dose groups, with eight subjects in each dose group.
Subjects will be randomized in 3:1 ratio to receive a single SC injection of MOD-5014 (n=6)
or a placebo (n=2), and will be followed up for 30 days. The initial MOD-5014 dose group will
receive 100 µg/kg followed by single doses of 200, 400 and 600 µg/kg administered to
subsequent subject cohorts.
The decision to proceed to the higher dose level will be made by a Data Safety Monitoring
Board (DSMB) after review of relevant safety data (including adverse events, clinical
laboratory and vital signs), collected up to and including 7 days after the last subject of
the previous dose group has been dosed.
Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be used to determine
maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Dose escalation will be
permitted if the prior dose is well tolerated, and there are no safety or tolerability
concerns raised by the investigator, sponsor, medical monitor or DSMB over 7 days
post-dosing.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00851721 -
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
|
Phase 3 | |
| Completed |
NCT02764489 -
FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
|
Phase 3 |