Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
2 other identifiers
interventional
18
1 country
1
Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 17, 2016
February 1, 2016
1 month
June 24, 2015
February 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AUC(0-tlast)
Area under the blood concentration vs time curve from zero to the last data point \> lower limit of quantification
Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Study Arms (2)
BAY81-8973
EXPERIMENTALBAY81-8973 infusion to analyze pharmacokinetics
Advate
OTHERAdvate infusion to analyze pharmacokinetics.
Interventions
Eligibility Criteria
You may qualify if:
- Males, age 18 to 65 years
- Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
You may not qualify if:
- Evidence of current or past inhibitor antibody
- History of any congenital or acquired coagulation disorders other than hemophilia A
- Platelet count \<75,000/mm3
- Abnormal renal function (serum creatinine \>2 times the upper limit of the normal \[ULN\] range)
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times the ULN or severe 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Sofia, 1756, Bulgaria
Related Publications (1)
Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.
PMID: 28005225DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 26, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
February 17, 2016
Record last verified: 2016-02