Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Baxalta US Inc. Official(s) and/or principal investigator(s): Baxter Bio Science Investigator, Study Director, Affiliation: Baxter Healthcare Corporation
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%).
Clinical Details
Official title: Pharmacokinetic Comparison of 3000 IU Advate (rAHF-PFM) (Using One 3000 IU Potency Vial) With 3000 IU Advate (rAHF PFM) (Using Two 1500 IU Potency Vials) in Previously Treated Patients With Severe Hemophilia A: a Phase 4, Open-label, Prospective, Randomized, Controlled, Crossover, Multiple Center Study
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic AssayArea Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay
Secondary outcome: Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic AssayArea Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay Incremental Recovery at Cmax - Chromogenic Assay Incremental Recovery at Cmax - One-stage aPTT Assay Incremental Recovery at 30 Minutes- Chromogenic Assay Incremental Recovery at 30 Minutes- One-stage aPTT Assay Elimination Phase Half-life- Chromogenic Assay Elimination Phase Half-life- One-stage aPTT Assay FVIII Clearance- Chromogenic Assay FVIII Clearance- One-stage aPTT Assay Mean Residence Time (MRT)- Chromogenic Assay Mean Residence Time (MRT)- One-stage aPTT Assay Volume of Distribution at Steady State- Chromogenic Assay Volume of Distribution at Steady State- One-stage aPTT Assay Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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% of
normal, as tested at screening at the central laboratory
- Participant's weight is between 55-65 kg
- Participant was previously treated with FVIII concentrate(s) for a minimum of 150
exposure days prior to study entry
- If Participant is HIV positive, he must be immunocompetent as determined with a CD4
count ≥ 200 cells/mm³ (CD4 count at screening)
- Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Participant has a detectable FVIII inhibitor at screening, with a titer ≥ 0. 4
Bethesda unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the
central laboratory
- Participant has a history of FVIII inhibitors with a titer ≥ 0. 4 BU (by Nijmegen
assay) or ≥ 0. 5 BU (by Bethesda Assay) at any time prior to screening
- Participant has undergone a surgery within 21 days prior to screening or within 6
weeks prior to the anticipated first pharmacokinetics(PK) infusion
- Participant has an abnormal renal function (serum creatinine > 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.
Locations and Contacts
Sofia 1233, Bulgaria
Kirov, Russian Federation
Moscow 125167, Russian Federation
St. Petersburg 195213, Russian Federation
Additional Information
Starting date: June 2009
Last updated: June 26, 2015
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