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NCT05568459 · ClinicalTrials.gov registry record
A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy
A clinical trial of Hemophilia B, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- 11
- Enrollment target
- 17
- Study locations
NCT05568459 is a study of Hemophilia B that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 11 participants, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (89% lower). The trial reports 17 study locations across 14 states.
The verdict
NCT05568459, a study of Hemophilia B, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- 11 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individual participant while they continue to use their usual FIX replacement therapy. There is no experimental treatment being tested in this study. The study is informational, and part of a larger program to understand and treat Hemophilia B with a potential experimental new therapy in the future. There is no obligation to agree to taking part in this future study. The study is looking to answer several other research questions to help understand each participant's individual disease characteristics, including: * How often to use FIX replacement therapy, both on a regular basis (prophylaxis) and as needed to treat bleeding events * Measurement of FIX activity (factor IX is a clotting factor) by different laboratories using different types of tests in Hemophilia B participants * Possible complications from the FIX replacement therapy the patient receives (usual standard of care will continue to be used) * How quality of life is affected by Hemophilia B * How joint health is affected by Hemophilia B * How often the participant visits the emergency room, urgent care center, physician's office, hospital, or has a telemedicine visit as a result of bleeding events * Whether the body makes antibodies (a protein produced by the body's immune system) against the FIX replacement therapy you receive, which could make the drug less effective or could lead to side effects
Conditions Studied
Interventions
- OTHER Non-Interventional
Study Locations (17)
Other
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt - Frankfurt
- University Hospital Hamburg Eppendorf - Hamburg
- Barts Health NHS Trust, Royal London Hospital - London
- St. Thomas' Hospital - London
Colorado
- University of Colorado Hemophilia and Thrombosis Center - Aurora
Connecticut
- Yale HTC - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- University of Florida - Gainesville
Illinois
- Rush University Medical Center - Chicago
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2024-01-17 |
| Est. Completion | 2026-05-21 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05568459
The ClinicalTrials.gov registry entry for NCT05568459 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (89% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia B appearing as the primary indexed condition, and to 1 intervention - of which Non-Interventional is the first listed.
NCT05568459 reports 17 study locations spanning 14 distinct geographic areas - top geographies include Other, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05568459 about?
NCT05568459 is a clinical study titled "A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy". This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individ...
What is the current status of trial NCT05568459?
This trial is currently active not recruiting. The enrollment target is 11 participants. The study started on 2024-01-17. Estimated completion is 2026-05-21.
What conditions does trial NCT05568459 study?
This clinical trial studies the following conditions: Hemophilia B.
What interventions are being tested in trial NCT05568459?
The interventions under investigation include: Non-Interventional (OTHER).
Who is sponsoring clinical trial NCT05568459?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05568459 being conducted?
This trial has 17 study locations across Colorado, Connecticut, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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