A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B

Status:	Active, not recruiting
Conditions:	Anemia, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - 65
Updated:	1/6/2019
Start Date:	May 2015
End Date:	April 2019

A Phase 1/2a, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) Profile of a Long Acting Recombinant FVIIa (MOD-5014) in Adult Men With Hemophilia A or B

The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the
acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult
subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open
label, dose-escalating study. Each dose cohort will be concluded by a safety review,
following which escalation to the next dose cohort will be approved.

Inclusion Criteria:

- Diagnosis of moderate or severe congenital Hemophilia A or B with or without
inhibitors

Exclusion Criteria:

- Diagnosis of any coagulation disorder other than Hemophilia A or B

- Receipt of any immunomodulatory therapy within 3 months prior to screening, with the
exception of Hepatitis C or HIV therapy

- Have had, within one month prior to study drug administration, a major surgical
procedure (e.g. orthopedic, abdominal) or have an elective surgery planned within the
study period

- Use of any anticoagulant for arterial/venous obstructions and/or atrial fibrillation
within 7 days prior to first study drug administration

- Malignancy within past 5 years (excluding non-melanoma skin cancer)

We found this trial at

sites

U.T. Southwestern Medical Center

2201 Inwood Rd
Dallas, Texas 75235

(214) 645-8300