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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: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT00952822 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method
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 |
What the finished NCT00952822 record still lists
NCT00952822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00952822's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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