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NCT00816660 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00816660: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT00816660 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00816660, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the immediate tolerability and safety of rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various dosages of VWF:RCo.
Interventions
- BIOLOGICAL Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII)
- BIOLOGICAL Marketed plasma-derived VWF/FVIII concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-12-01 |
| Est. Completion | 2010-08-31 |
| Phase | Phase 1 |
What the finished NCT00816660 record still lists
NCT00816660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII) is the first listed.
NCT00816660 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00816660 about?
NCT00816660 is a clinical study titled "Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease". The objectives of this study are to evaluate the immediate tolerability and safety of rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various dosages of VWF:RCo.
What is the current status of trial NCT00816660?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2008-12-01. Estimated completion is 2010-08-31.
What interventions are being tested in trial NCT00816660?
The interventions under investigation include: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII) (BIOLOGICAL), Marketed plasma-derived VWF/FVIII concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00816660?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00816660's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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