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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 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.

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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

Hemophilia A

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

FieldValue
Enrollment Target 11 participants
Start Date 2018-11-07
Est. Completion 2026-11-03
Phase Phase 1

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT03588299

The ClinicalTrials.gov registry entry for NCT03588299 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (88% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.