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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT02418793

Public ClinicalTrials.gov record NCT02418793. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 31, 2026, 3:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02418793
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
OPKO Health, Inc.
Industry
Enrollment
27 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2015 (Type not available)
Primary completion
Sep 2018 (Actual)
Completion
Sep 2018 (Actual)
Last update posted
May 20, 2021

2015 – 2018

United States locations

U.S. sites
11
U.S. states
5
U.S. cities
10
Facility City State ZIP Site status
City of Hope Duarte California — —
Children's Hospital Los Angeles Los Angeles California 90027 —
Orthopaedic Hemophilia Treatment Center Los Angeles California — —
University of California Davis Medical Center Sacramento California — —
Rush University Medical Center Chicago Illinois — —
Bleeding & Clotting Disorders Institute Peoria Illinois — —
Indiana Hemophilia & Thrombosis Center Indianapolis Indiana — —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania — —
UPMC Presbyterian Shadyside Pittsburgh Pennsylvania — —
UT Southwestern Medical Center Dallas Texas — —
The Gulf States Hemophilia and Thrombophilia Center Houston Texas — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02418793, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 20, 2021 · Synced Oct 31, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02418793 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →