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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: Completed Phase 1 study, sponsored by OPKO Health.
NCT02418793 is a Phase 1 study that has completed, run by OPKO Health. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the acute safety and tolerability of single intravenous (IV) administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.
Interventions
- DRUG MOD-5014
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
What the finished NCT02418793 record still lists
NCT02418793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which MOD-5014 is the first listed.
NCT02418793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02418793's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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