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NCT00952822 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00952822 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 52 participants.
The verdict
NCT00952822, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.
Interventions
- BIOLOGICAL Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2008-08-08 |
| Est. Completion | 2009-10-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00952822
The ClinicalTrials.gov registry entry for NCT00952822 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 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 1 intervention - of which Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII) is the first listed.
NCT00952822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00952822 about?
NCT00952822 is a clinical study titled "Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection". The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.
What is the current status of trial NCT00952822?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2008-08-08. Estimated completion is 2009-10-23.
What interventions are being tested in trial NCT00952822?
The interventions under investigation include: Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00952822?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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