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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 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 32 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00816660
The ClinicalTrials.gov registry entry for NCT00816660 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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