Fibrinogen Deficiency Clinical Trial
Official title:
Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | May 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years and older |
| Eligibility |
Inclusion Criteria: - Aged = 6 years - Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL) - Informed consent signed by subject or legal guardian Exclusion Criteria: - Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins, - Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis - Acute bleeding - History of esophageal varicose bleeding - End stage liver disease (i.e. Child-Pugh score B or C) - Planned major surgery with a need for blood transfusion during the PK blood sampling period - Polytrauma within 1 year prior to enrollment |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Contact CSL Behring for facility details | Cagliari | |
| Italy | Contact CSL Behring for facility details | Firenze | |
| Italy | Contact CSL Behring for facility details | Milano | |
| Italy | Contact CSL Behring for facility details | Napoli | |
| Italy | Contact CSL Behring for facility details | Padova | |
| Italy | Contact CSL Behring for facility details | Palermo | |
| Italy | Contact CSL Behring for facility details | Rome | |
| Italy | Contact CSL Behring for facility details | Sassari | |
| Italy | Contact CSL Behring for facility details | Vicenza | |
| United States | Contact CSL Behring for facility details | Aurora | Colorado |
| United States | Contact CSL Behring for facility details | Chicago | Illinois |
| United States | Contact CSL Behring for facility details | New York | New York |
| United States | Contact CSL Behring for facility details | Pittsburgh | Pennsylvania |
| United States | Contact CSL Behring for facility details | Scarborough | Maine |
| United States | Contact CSL Behring for facility details | St. Petersburg | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring |
United States, Italy,
Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum Clot Firmness (MCF) | 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. | Pre-infusion and 1 hour post-infusion | No |
| Secondary | Terminal Elimination Half-life (t1/2) | t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | 0.5 hours to 13 days post-infusion | No |
| Secondary | Maximum Concentration (Cmax) | Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | Pre-infusion to 13 days post-infusion | No |
| Secondary | Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose | AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | Pre-infusion to 13 days post-infusion | No |
| Secondary | Clearance (Cl) | Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | Pre-infusion to 13 days post-infusion | No |
| Secondary | Mean Residence Time (MRT) | MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame. | Pre-infusion to 13 days post-infusion | No |
| Secondary | Volume of Distribution at Steady State (Vss) | Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame. | Pre-infusion to 13 days post-infusion | No |
| Secondary | Incremental In Vivo Recovery (IVR) | Maximum fibrinogen activity increase in plasma per mg/kg dosed | Pre-infusion to 4 hours post-infusion | No |
| Secondary | Classical In Vivo Recovery (IVR) | Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose | Pre-infusion to 4 hours post-infusion | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT00916656 -
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
|
Phase 3 |