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NCT06003387 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

A Phase 3 study of Hemophilia B, sponsored by CSL Behring.

Recruiting
Registry status
Phase 3
Development phase
35
Enrollment target
20
Study locations

NCT06003387 is a Phase 3 study of Hemophilia B that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 35 participants, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06003387, a Phase 3 study of Hemophilia B, is actively recruiting participants, sponsored by CSL Behring.

RECRUITING
Registry status
Phase 3
Development phase
35 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.

Conditions Studied

Hemophilia B

Interventions

  • GENETIC CSL222 (AAV5-hFIXco-Padua)

Study Locations (20)

Other

  • Queen Mary Hospital - Hong Kong
  • Prince of Wales Hospital Chinese University of Hong Kong - Shatin
  • Sheba Medical Center - Tel Litwinsky
  • King Faisal Specialist Hospital and Research Center - Riyadh
  • National University Hospital - Singapore
  • Singapore General Hospital - Singapore
  • Haemophilia Comprehensive Care Centre - Johannesburg
  • Kyungpook National University Hospital - Daegu
  • Kyung Hee University Hospital at Gangdong - Seoul
  • Severance Hospital, Yonsei University Health System - Seoul

California

  • University of California, San Diego (UCSD) - San Diego

Michigan

  • University of Michigan - Ann Arbor

New South Wales

  • Royal Prince Alfred Hospital - Camperdown

Queensland

  • Royal Brisbane Hospital - Herston

South Australia

  • Royal Adelaide Hospital - Adelaide

Victoria

  • The Alfred Hospital - Melbourne

Ontario

  • McMaster University - Hamilton - Hamilton

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2024-01-30
Est. Completion 2032-04-02
Phase Phase 3

Sponsor

CSL Behring

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06003387

The ClinicalTrials.gov registry entry for NCT06003387 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (63% lower). The listed sponsor is CSL Behring, which has 71 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 CSL222 (AAV5-hFIXco-Padua) is the first listed.

NCT06003387 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT06003387 about?

NCT06003387 is a clinical study titled "Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)". The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.

What is the current status of trial NCT06003387?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2024-01-30. Estimated completion is 2032-04-02.

What conditions does trial NCT06003387 study?

This clinical trial studies the following conditions: Hemophilia B.

What interventions are being tested in trial NCT06003387?

The interventions under investigation include: CSL222 (AAV5-hFIXco-Padua) (GENETIC).

Who is sponsoring clinical trial NCT06003387?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06003387 being conducted?

This trial has 20 study locations across California, Michigan, New South Wales, Queensland, South Australia. 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.