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NCT01513200 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia
A Phase 1 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01513200: Completed Phase 1 study, sponsored by Stealth BioTherapeutics.
NCT01513200 is a Phase 1 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01513200, a Phase 1 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.
Primary Outcome
Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (Analysis of Variance; ANOVA) at the following time points: Pre-UFH, Pre-Study-Drug infusion start and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours Post-Study-Drug infusion start.
Interventions
- DRUG Unfractionated heparin (UFH)
- DRUG Bendavia
- DRUG Saline (0.9%, sterile, for infusion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01513200 record still lists
NCT01513200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Unfractionated heparin (UFH) is the first listed.
NCT01513200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01513200 about?
NCT01513200 is a clinical study titled "Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia". This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.
What is the current status of trial NCT01513200?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-01. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01513200?
The interventions under investigation include: Unfractionated heparin (UFH) (DRUG), Bendavia (DRUG), Saline (0.9%, sterile, for infusion) (DRUG).
Who is sponsoring clinical trial NCT01513200?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01513200's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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