Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for t...
Eligibility Criteria
Inclusion
- Participants with severe hemophilia A (baseline FVIII activity FVIII:C \<1%), determined by measurement at the time of screening (following a washout period of at least 72 h after their last FVIII treatment for standard half-life FVIII products or of 120 h for extended half-life FVIII products) or from reliable prior documentation (e.g. measurement in other clinical studies, result from approved clinical laboratory or diagnostic genetic testing).
- ≥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
- Inability to stop FVIII treatment to complete a minimum of 72 h washout for standard half-life FVIII product or 120 h washout for extended half-life FVIII product
- 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
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04015492
Start Date
August 8 2019
End Date
January 29 2020
Last Update
December 21 2020
Active Locations (1)
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1
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, Bulgaria, 1756