drugset / Trial / NCT00496262
Human Fibrinogen - Pharmacokinetics
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-07
- Primary completion
- 2008-05
- Completion
- 2008-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 70 mg/kg | Intravenous |