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NCT06008938 · ClinicalTrials.gov registry record
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
A clinical trial of Hemophilia B, sponsored by CSL Behring.
- Recruiting
- Registry status
- 500
- Enrollment target
- 12
- Study locations
NCT06008938: Recruiting study of Hemophilia B, sponsored by CSL Behring.
NCT06008938 is a study of Hemophilia B that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 500 participants, above the 72-participant average among 20 other Hemophilia B trials with a reported enrollment target (594% higher). The trial reports 12 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06008938, a study of Hemophilia B, is actively recruiting participants, sponsored by CSL Behring.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 12
- Study locations
Study Summary
This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.
Primary Outcome
Annualised Bleeding Rate (ABR) for all bleeds
Conditions Studied
Interventions
- GENETIC HEMGENIX
- BIOLOGICAL Factor IX (FIX)
Study Locations (12)
Other
- Medical University Vienna - Vienna
- Aarhus Universitetshospital - Århus N
- Centre Hospitalier Universitaire de Brest / CHU Morvan - Brest
- Centre Régional de Traitement de l'Hémophilie - Nantes
- CHU Nancy - Hôpital Brabois - Vandœuvre-lès-Nancy
- Klinik für Angiologie/ Hämostaseologie - Berlin
- University of Clinic Bonn - Bonn
- Klinikum der Johann-Wolfgang Goethe Universitaet - Frankfurt
- Hannover Medical School - Hanover
- Hospital Alvaro Cunqueiro Dr. Manuel Rodriquez-Lopez - Vigo
- University Hospital Bern Inselspital - Bern
New York
- American Thrombosis and Hemostasis Network - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2043-08-01 |
What NCT06008938 shows while recruiting
NCT06008938 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 20 other Hemophilia B trials with a reported enrollment target (594% higher).
The record links to 1 condition, with Hemophilia B appearing as the primary indexed condition, and to 2 interventions - of which HEMGENIX is the first listed.
NCT06008938 lists 12 locations in 2 states (Other, New York).
Frequently Asked Questions
What is clinical trial NCT06008938 about?
NCT06008938 is a clinical study titled "An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B". This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation o...
What is the current status of trial NCT06008938?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2023-06-15. Estimated completion is 2043-08-01.
What conditions does trial NCT06008938 study?
This clinical trial studies the following conditions: Hemophilia B.
What interventions are being tested in trial NCT06008938?
The interventions under investigation include: HEMGENIX (GENETIC), Factor IX (FIX) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06008938?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06008938 being conducted?
This trial has 12 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06008938's enrollment target sits among peer trials
500 1st of 20 higher than 20 of 20 other Hemophilia B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia B 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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