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HEMA Biologics

Our Investigational Treatment

Eptacogum Beta, activated (LR769)*: Recombinant Coagulation Factor VIIa

Eptacog Beta (LR769) is a recombinant form of human factor VIIa under FDA review for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors. Currently, two additional phase 3 trials are investigating the use of eptacog beta in pediatric and surgical patients with hemophilia A or B with inhibitors.

* Eptacogum beta, activated is the International Nomenclature Name for the molecule

Our Clinical Trials

Eptacog Beta Studies*

Investigating Eptacog Beta for the on-demand treatment of patients with hemophilia A or B with inhibitors**
*Disclosure: Eptacog beta has not received approval from the Food and Drug Administration (FDA). This information is not intended to draw any conclusions regarding the efficacy and safety of eptacog beta for any indication or dosage.
**PERSEPT: Program for the Evaluation of Recombinant factor Seven Efficacy by Prospective clinical Trials

Phase
1 2 3 4
Dose-Ranging Study (N=15)
Phase 1b
Study Design
Dose escalation, pharmacokinetics, safety and in vivo pharmacodynamics
Ducore, et al. 2017
NCT01708564
doi: 10.1111/hae.13357

Status
Completed

Population
Adults
Hemophilia A or B patients with or without inhibitors, non-bleeding
(20-61 years)
View Study Details
PERSEPT 1 (N=27)
Phase 3a
Study Design
Efficacy, safety, and immunogenicity
Wang, et al. 2017
NCT02020369
doi: 10.1111/hae.13301

Status
Completed

Population
Adolescents & Adults
(12-75 years)
View Study Details
Phase
1 2 3 4
PERSEPT 2 (N=24)
Phase 3b
Study Design
Efficacy, safety, and immunogenicity
NCT02448680

Status
Completed

Population
Children
(6 months-11 years)
View Study Details
PERSEPT 3
Phase 3b
Study Design
Efficacy and safety in the prevention of excess surgical hemorrhage
NCT02548143

Status
Completed

Population
Children & Adults
(6 months-75 years)
View Study Details