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NCT03588299 · ClinicalTrials.gov registry record · Phase 1
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"
A Phase 1 study of Hemophilia A, sponsored by Bayer.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 13
- Study locations
NCT03588299: Active Phase 1 study of Hemophilia A, sponsored by Bayer.
NCT03588299 is a Phase 1 study of Hemophilia A that is active but no longer recruiting, run by Bayer. The registered enrollment target is 11 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (88% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03588299, a Phase 1 study of Hemophilia A, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG BAY2599023 (DTX201)
Study Locations (13)
Other
- Vivantes Klinikum im Friedrichshain - Berlin
- Universitair Medisch Centrum Groningen - Groningen
- University Medical Center Utrecht - Utrecht
Arkansas
- Arkansas Children's Hospital - Hematology / Oncology - Little Rock
Michigan
- C.S. Mott Children's Hospital - Hematology / Oncology - Ann Arbor
Wisconsin
- UW Health Carbone Cancer Center - Madison
Sofia City Province
- SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD - Sofia
Brittany Region
- CHU Rennes - Hopital Pontchaillou - Rennes
Île-de-France Region
- APHP-Hopital Necker Enfants malades - Paris
Saarland
- Universitätsklinikum des Saarlandes - Homburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2026-11-03 |
| Phase | Phase 1 |
What the registry record for NCT03588299 still lists
NCT03588299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which BAY2599023 (DTX201) is the first listed.
NCT03588299 lists 13 locations in 11 states (Other, Arkansas, Michigan).
Frequently Asked Questions
What is clinical trial NCT03588299 about?
NCT03588299 is a clinical study titled "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"". 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 b...
What is the current status of trial NCT03588299?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-11-07. Estimated completion is 2026-11-03.
What conditions does trial NCT03588299 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT03588299?
The interventions under investigation include: BAY2599023 (DTX201) (DRUG).
Who is sponsoring clinical trial NCT03588299?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03588299 being conducted?
This trial has 13 study locations across Arkansas, Michigan, Wisconsin, Sofia City Province, Brittany Region. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03588299's enrollment target sits among peer trials
11 37th of 42 higher than 6 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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