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NCT02618915 · ClinicalTrials.gov registry record · Phase 1
Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B
A Phase 1 study, sponsored by Ultragenyx Pharmaceutical.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02618915: Clinical Trial Phase 1 study, sponsored by Ultragenyx Pharmaceutical.
NCT02618915 is a Phase 1 study that was terminated before completion, run by Ultragenyx Pharmaceutical. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02618915, a Phase 1 study, was terminated before completion, sponsored by Ultragenyx Pharmaceutical.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant enrolled into this study (from the time the participant signed the informed consent form until his or her exit from the study), regardless of its causal relationship to study treatment. A TEAE was defined as any event not present before exposure to study product or any event already present that worsened in severity or increased in frequency after exposure to study product.
Interventions
- GENETIC DTX101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-12-16 |
| Est. Completion | 2017-10-18 |
| Phase | Phase 1 |
Why NCT02618915 stopped before completion
NCT02618915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which DTX101 is the first listed.
NCT02618915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02618915 about?
NCT02618915 is a clinical study titled "Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B". A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.
What is the current status of trial NCT02618915?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-12-16. Estimated completion is 2017-10-18.
What interventions are being tested in trial NCT02618915?
The interventions under investigation include: DTX101 (GENETIC).
Who is sponsoring clinical trial NCT02618915?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02618915's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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