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NCT02418793 · ClinicalTrials.gov registry record · Phase 1
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
A Phase 1 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02418793 is a Phase 1 study that has completed, run by OPKO Health. The registered enrollment target is 27 participants.
The verdict
NCT02418793, a Phase 1 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Interventions
- DRUG MOD-5014
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02418793
The ClinicalTrials.gov registry entry for NCT02418793 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MOD-5014 is the first listed.
NCT02418793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02418793 about?
NCT02418793 is a clinical study titled "A Study of a Long-Acting r-Factor 7a (Factor VIIa) 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-escalatin...
What is the current status of trial NCT02418793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-05. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02418793?
The interventions under investigation include: MOD-5014 (DRUG).
Who is sponsoring clinical trial NCT02418793?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
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