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RECRUITING

An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

NCT06008938 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 500 participants
Start Date 2023-06-15
Est. Completion 2043-08-01

Sponsor

CSL Behring

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06008938

The ClinicalTrials.gov registry entry for NCT06008938 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06008938 reports 12 study locations spanning 2 distinct geographic areas — top geographies include Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06008938?

The interventions under investigation include: HEMGENIX (GENETIC), Factor IX (FIX) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06008938?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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