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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03364998 |
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Date of registration:
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30/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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BAY94-9027 PK Study Comparing to Another Long Acting Product
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Scientific title:
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Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta |
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Date of first enrolment:
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November 30, 2017 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03364998 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Bulgaria
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hemophilia A
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Intervention(s)
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Drug: Elocta
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Drug: Damoctocog (Jivi, BAY94-9027)
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Primary Outcome(s)
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AUC from time 0 to the last data point
[Time Frame: Pre-Dose and up to 120 hours post dose]
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Secondary ID(s)
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2017-003201-18
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19096
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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