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NCT00496262 · ClinicalTrials.gov registry record · Phase 2
Human Fibrinogen - Pharmacokinetics
A Phase 2 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00496262: Completed Phase 2 study, sponsored by CSL Behring.
NCT00496262 is a Phase 2 study that has completed, run by CSL Behring. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496262, a Phase 2 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.
Primary Outcome
MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.
Interventions
- BIOLOGICAL Human Fibrinogen Concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00496262 record still lists
NCT00496262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Fibrinogen Concentrate is the first listed.
NCT00496262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496262 about?
NCT00496262 is a clinical study titled "Human Fibrinogen - Pharmacokinetics". This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibr...
What is the current status of trial NCT00496262?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2007-07. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00496262?
The interventions under investigation include: Human Fibrinogen Concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00496262?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496262's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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