Back to resultsBAY94-9027 PK Study Comparing to Another Long Acting Product
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 1
Locations
Bulgaria
Study Type
Interventional
Intervention
Damoctocog (Jivi, BAY94-9027)
Elocta
Sponsored by
About this trial
This is an interventional basic science trial for Hemophilia A
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Evidence of current or past inhibitor antibody:
- History of any congenital or acquired coagulation disorders other than hemophilia A.
- Platelet count <75,000/mm*3.
- Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
Sites / Locations
- SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BAY94-9027 and Elocta
Elocta and BAY94-9027
Arm Description
Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment
Outcomes
Primary Outcome Measures
AUC from time 0 to the last data point
Area under the concentration time profile curve.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03364998
Brief Title
BAY94-9027 PK Study Comparing to Another Long Acting Product
Official Title
Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY94-9027 and Elocta
Arm Type
Experimental
Arm Description
Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
Arm Title
Elocta and BAY94-9027
Arm Type
Experimental
Arm Description
Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment
Intervention Type
Drug
Intervention Name(s)
Damoctocog (Jivi, BAY94-9027)
Intervention Description
60 international units (IU)/kg, given as a 10 minute injection, 1 dose
Intervention Type
Drug
Intervention Name(s)
Elocta
Intervention Description
60 IU/kg, given as a 10 minute injection, 1 dose
Primary Outcome Measure Information:
Title
AUC from time 0 to the last data point
Description
Area under the concentration time profile curve.
Time Frame
Pre-Dose and up to 120 hours post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Evidence of current or past inhibitor antibody:
History of any congenital or acquired coagulation disorders other than hemophilia A.
Platelet count <75,000/mm*3.
Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
Facility Information:
Facility Name
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
12. IPD Sharing Statement
Citations:
PubMed Identifier
31236667
Citation
Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24.
Results Reference
derived
Links:
URL
http://clinicaltrials.bayer.com/
Description
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Learn more about this trial
BAY94-9027 PK Study Comparing to Another Long Acting Product
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