Phase 1
Completed N=42
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
Source: ClinicalTrials.gov NCT00952822 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Jul 2011
Primary outcomePrimary: Area Under the Curve — 1257.20; 1297.42 IU*h/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve |
1257.20; 1297.42 | — |
| SECONDARY Total Area Under the Curve |
1357.60; 1368.12 | — |
| SECONDARY Adjusted in Vivo Incremental Recovery |
1.87; 1.88; 1.33; 1.66 | — |
| SECONDARY Terminal Half-life |
12.54; 12.50 | — |
| SECONDARY Weight-Adjusted Clearance |
3.85; 3.81 | — |
| SECONDARY Mean Residence Time |
14.79; 14.34 | — |
| SECONDARY Volume of Distribution at Steady State |
0.54; 0.51 | — |
| SECONDARY Maximum Plasma Concentration |
102.77; 106.46 | — |
| SECONDARY Number and Severity of Infusion Site Reactions |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Infusion Site Pain |
0; 0; 8; 4; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- The subject or subject's legally authorized representative has provided written informed consent
- The subject has severe hemophilia A as defined by a baseline FVIII activity = 12 to = 2 to 60
- The subject is human immunodeficiency virus negative (HIV-) or HIV+ with stable CD4 count >= 200 cells/mm³ (CD4 count determined at screening, if necessary)
Exclusion Criteria
- The subject has a known hypersensitivity to mouse or hamster proteins or to FVIII concentrates
- The subject has a history of FVIII inhibitors with titer >= 0. 5 BU (Bethesda Assay) or >= 0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening
- The subject has a detectable FVIII inhibitor at screening, >= 0.4 BU (Nijmegen modification of the Bethesda Assay), in the central laboratory
- The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
- The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or Von Willebrand Disease)
- The subject has received another investigational product within 30 days of enrollment
- The subject's clinical condition may require major or moderate surgery (estimated blood loss > 500 mL) during the period of participation in the study
- Subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- The subject is a female of childbearing potential with a positive pregnancy test at screening
Data sourced from ClinicalTrials.gov (NCT00952822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.