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

Completed · Phase 1

Conditions studied: Hemophilia A, Hemophilia B

In brief

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.

Key facts

Study ID

NCT02418793

Run by

OPKO Health, Inc.

People needed

27

Starts

2015-05-01

Expected to finish

2018-09-01

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• City of Hope — Duarte, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Orthopaedic Hemophilia Treatment Center — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Bleeding & Clotting Disorders Institute — Peoria, Illinois, United States
• Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• UPMC Presbyterian Shadyside — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• The Gulf States Hemophilia and Thrombophilia Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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