Madison, Wisconsin 53792

  • Hemophilia A

Purpose:

In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the disease. By replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. Hemophilia A is a bleeding disorder in which the human body does not have enough clotting factor VIII, a protein that controls bleeding. Researcher want to find the optimal dose of BAY 2599023 (DTX201) so that the body may produce enough clotting factor on its own.


Criteria:

Inclusion Criteria: - Males age 18 years or older. - Confirmed diagnosis of hemophilia A as evidenced by their medical history with plasma FVIII activity levels < 1% of normal or at screening. - Have >150 exposure days (EDs) to FVIII concentrates (recombinant or plasma-derived). If on prophylaxis, are required to be willing to stop prophylactic treatment at specified time points throughout the study or If on-demand: should have had > 4 bleeding events in the last 52 weeks - Agree to use reliable barrier contraception. Exclusion Criteria: - History of allergic reaction to any FVIII product. - Clinically relevant findings in the physical examination considered critical by the treating physician, including obesity with BMI > 35 kg/m*2 - Current evidence of measurable inhibitor against factor VIII, as assessed by the central laboratory and/or prior history of inhibitors to FVIII protein. - Evidence of active hepatitis B or C. - Currently on antiviral therapy for hepatitis B or C. - Significant underlying liver disease. - Serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm*3; HIV+ and stable participants with CD4 count >200/mm*3 and undetectable viral load are eligible to enroll. - Detectable antibodies reactive with AAVhu37capsid. - Participant with another bleeding disorder that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B). - Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks. - Known or suspected hypersensitivity or allergic reaction to trial product(s) or related FVIII products or any component of BAY2599023 (DTX201), or a contraindication to prednisolone


NCT ID:

NCT03588299


Primary Contact:

Bayer Clinical Trials Contact
Phone: (+) 1-888-8422937
Email: clinical-trials-contact@bayer.com


Backup Contact:

For trial location information (Phone Menu Options '3' or '4')
Phone: (+)1-888-84 22937


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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