Phase 4
N=23
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT00916032 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay — 1158; 1264 (IU·h)/dL — p=0.103
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Baxalta now part of Shire
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay |
1158; 1264 | 0.103 |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay |
1129; 1226 | 0.162 |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay |
1267; 1383 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay |
1235; 1348 | — |
| SECONDARY Incremental Recovery at Cmax - Chromogenic Assay |
1.81; 2.04 | — |
| SECONDARY Incremental Recovery at Cmax - One-stage aPTT Assay |
1.75; 1.96 | — |
| SECONDARY Incremental Recovery at 30 Minutes- Chromogenic Assay |
1.62; 1.84 | — |
| SECONDARY Incremental Recovery at 30 Minutes- One-stage aPTT Assay |
1.64; 1.90 | — |
| SECONDARY Elimination Phase Half-life- Chromogenic Assay |
13.27; 12.84 | — |
| SECONDARY Elimination Phase Half-life- One-stage aPTT Assay |
13.80; 13.50 | — |
| SECONDARY FVIII Clearance- Chromogenic Assay |
4.57; 3.99 | — |
| SECONDARY FVIII Clearance- One-stage aPTT Assay |
4.66; 4.06 | — |
| SECONDARY Mean Residence Time (MRT)- Chromogenic Assay |
17.02; 16.84 | — |
| SECONDARY Mean Residence Time (MRT)- One-stage aPTT Assay |
16.95; 17.16 | — |
| SECONDARY Volume of Distribution at Steady State- Chromogenic Assay |
0.72; 0.61 | — |
| SECONDARY Volume of Distribution at Steady State- One-stage aPTT Assay |
0.74; 0.64 | — |
| SECONDARY Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay |
94; 101 | — |
| SECONDARY Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay |
91; 98 | — |
Summary
The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL diluent in total) in previously treated patients with severe hemophilia A (factor VIII level < 1%).
Eligibility Criteria
Inclusion Criteria
- Participant is 18 to 65 years old, at the time of screening
- Participant has provided signed informed consent
- Participant has severe hemophilia A, defined by a baseline FVIII level 1.5 mg/dL)
- Participant has active hepatic disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >5 times the upper limit of normal)
- Participant 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
- Participant has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (eg, late-stage chronic liver disease, immune thrombocytopenia purpura)
- Participant is currently receiving, or is scheduled to receive during the course of the clinical study, an immunomodulating drug other than anti-retroviral chemotherapy (eg, alfa-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day)
- Participant has a known hypersensitivity to mouse or hamster proteins
- Participant has participated in another clinical study involving an investigational product or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this clinical study
- Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
- Participant is a member of the team conducting this clinical study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, or parents) as well as employees of the investigator or site personnel conducting the clinical study.
Data sourced from ClinicalTrials.gov (NCT00916032). 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.