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Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle"

StatusCompleted
PhasePhase 1/2
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 98 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Study sites revised (13) Show 1 more changeShow less
    • Study sites revised (13)
  2. Re-verified, no change to tracked fieldsv97
  3. Primary and study completion moved earlier from Nov 3, 2026 to Sep 15, 2026v96
  4. 2 versions Re-verified since Apr 16, 2026, no change to tracked fieldsv94-v95
  5. Site details revised at 2 of 13 sitesv93
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 3 of 13 sitesv92
  2. Re-verified, no change to tracked fieldsv91
  3. Site details revised at 1 of 13 sitesv90
  4. Study sites revised (13)v89 See this version in full on ClinicalTrials.gov ↗
  5. 5 versions Re-verified since Apr 28, 2025, no change to tracked fieldsv84-v88
  6. Study sites revised (13)v83 See this version in full on ClinicalTrials.gov ↗
  7. Re-verified, no change to tracked fieldsv82
  8. Study sites revised (13)v81 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (13)v80 See this version in full on ClinicalTrials.gov ↗
  10. Completion date: Nov 30, 2026 to Nov 3, 2026v79
  11. Re-verified, no change to tracked fieldsv78
  12. Study Identification, Study Statusv77
  13. 24 versions Re-verified since Oct 10, 2022, no change to tracked fieldsv53-v76
  14. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 30 to confirmed 11 · Study sites: 25 to 13v52 Show 2 more changesShow less
    • Enrollment target: estimated 30 to confirmed 11
    • Study sites: 25 to 13
  15. Primary completion date: May 31, 2027 to Nov 3, 2026 Completion date: Jun 28, 2027 to Nov 30, 2026v51 Show 1 more changeShow less
    • Completion date: Jun 28, 2027 to Nov 30, 2026
  16. 2 versions Re-verified since Jun 9, 2022, no change to tracked fieldsv49-v50
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
Hemophilia
236 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT03588299
Lead Sponsor Bayer
Collaborators: Ultragenix pharmaceutical
Conditions Hemophilia A
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov