Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII)
NCT ID: NCT04015492
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2019-08-08
2020-01-29
Brief Summary
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Patients participating in this study will receive one dose of Jivi and one dose of Adynovi. Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood samples will be taken from the participants to measure the blood levels of FVIII. Generic name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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BAY94-9027 / Adynovi
Treatment sequence A-B with washout before each treatment
Damoctocog-alfa-pegol (BAY94-9027, Jivi)
Single dose, 50 IU/kg BAY94-9027 (IU: international Units)
Rurioctocog alfa pegol (Adynovi)
Single dose, 50 IU/kg Adynovi
Adynovi / BAY94-9027
Treatment sequence B-A with washout before each treatment
Damoctocog-alfa-pegol (BAY94-9027, Jivi)
Single dose, 50 IU/kg BAY94-9027 (IU: international Units)
Rurioctocog alfa pegol (Adynovi)
Single dose, 50 IU/kg Adynovi
Interventions
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Damoctocog-alfa-pegol (BAY94-9027, Jivi)
Single dose, 50 IU/kg BAY94-9027 (IU: international Units)
Rurioctocog alfa pegol (Adynovi)
Single dose, 50 IU/kg Adynovi
Eligibility Criteria
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Inclusion Criteria
* ≥150 exposure days with FVIII concentrate(s) (plasma-derived or recombinant) as supported by medical records.
* Body mass index (BMI) within the range 18 kg/m2 to 29.9 kg/m2 (inclusive).
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/mm3
* Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of \<200/mm3
* Abnormal renal function (serum creatinine \>2x the upper limit of the normal range \[ULN\])
* Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5x ULN 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
* Requirement of any pre-medication to tolerate FVIII treatment (e.g. anti-histamines)
* Prior treatment with immunomodulatory agents or chemotherapy within the last 3 months prior to study entry or requirement of treatment during the study. The following drugs are allowed: α interferon, PEG interferon, highly active anti-retroviral therapy for HIV, and/or a total of two courses of pulse treatment with steroid for a maximum of 7 days at 1 mg/kg or less
18 Years
65 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, , Bulgaria
Countries
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References
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Solms A, Shah A, Berntorp E, Tiede A, Iorio A, Linardi C, Ahsman M, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2020 Nov;99(11):2689-2698. doi: 10.1007/s00277-020-04280-3. Epub 2020 Sep 24.
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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2018-000507-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19742
Identifier Type: -
Identifier Source: org_study_id