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NCT04392739 · ClinicalTrials.gov registry record · Phase 4
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
A Phase 4 study, sponsored by SIGA Technologies.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT04392739: Completed Phase 4 study, sponsored by SIGA Technologies.
NCT04392739 is a Phase 4 study that has completed, run by SIGA Technologies. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04392739, a Phase 4 study, has completed, sponsored by SIGA Technologies.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
Safety and PK study in adults weighing more than 120 kg
Primary Outcome
Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Interventions
- DRUG Tpoxx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2019-12-05 |
| Phase | Phase 4 |
What the finished NCT04392739 record still lists
NCT04392739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Tpoxx is the first listed.
NCT04392739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04392739 about?
NCT04392739 is a clinical study titled "Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG". Safety and PK study in adults weighing more than 120 kg
What is the current status of trial NCT04392739?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2019-07-19. Estimated completion is 2019-12-05.
What interventions are being tested in trial NCT04392739?
The interventions under investigation include: Tpoxx (DRUG).
Who is sponsoring clinical trial NCT04392739?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04392739's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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