Brief Title
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
Official Title
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
Brief Summary
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
Secondary Outcome
Pharmacokinetic Profile
Condition
Hemophilia A
Intervention
MOD-5014
Study Arms / Comparison Groups
Dose Cohort 1
Description: Lowest MOD-5014 dose tested in the study
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
May 2015
Completion Date
September 2018
Primary Completion Date
September 2018
Eligibility Criteria
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)
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Guy Ben-Bashat, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02418793
Organization ID
CP-5-001
Responsible Party
Sponsor
Study Sponsor
OPKO Health, Inc.
Study Sponsor
Guy Ben-Bashat, Study Director, OPKO Health, Inc.
Verification Date
May 2021