A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
NCT ID: NCT02418793
Last Updated: 2021-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2015-05-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Cohort 1
Lowest MOD-5014 dose tested in the study
MOD-5014
Long Acting Factor VIIa
Dose Cohort 2
MOD-5014 Dose cohort 2
MOD-5014
Long Acting Factor VIIa
Dose Cohort 3
MOD-5014 Dose cohort 3
MOD-5014
Long Acting Factor VIIa
Dose Cohort 4
MOD-5014 Dose cohort 4
MOD-5014
Long Acting Factor VIIa
Dose Cohort 5
MOD-5014 Dose cohort 5
MOD-5014
Long Acting Factor VIIa
Dose Cohort 6
Highest MOD-5014 dose tested in the study
MOD-5014
Long Acting Factor VIIa
Interventions
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MOD-5014
Long Acting Factor VIIa
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
65 Years
MALE
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Guy Ben-Bashat
Role: STUDY_DIRECTOR
OPKO Health, Inc.
Locations
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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
Countries
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Other Identifiers
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CP-5-001
Identifier Type: -
Identifier Source: org_study_id
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