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AAV Gene Therapy Screening/Observational Protocol (ECLIPSE)

NCT04272554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2022-11-04

No results posted yet for this study

Summary

Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

Conditions

  • Hemophilia B
  • Blood Coagulation Disorders, Inherited
  • Blood Coagulation Disorder
  • Haematologic Disease

Sponsors & Collaborators

  • Spur Therapeutics

    lead INDUSTRY

Principal Investigators

  • Pratima Chowdary, Dr · The Royal Free Hospital

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2022-10-10
Completion
2022-10-10

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • South Africa
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272554 on ClinicalTrials.gov