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A Phase 1/2 Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of SIG-001 in Adult Patients With Severe or Moderately-Severe Haemophilia A Without Inhibitors (SIG-001-121)

Trial Profile

A Phase 1/2 Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of SIG-001 in Adult Patients With Severe or Moderately-Severe Haemophilia A Without Inhibitors (SIG-001-121)

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs SIG 001 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man
  • Sponsors Sigilon Therapeutics
  • Most Recent Events

    • 07 Nov 2022 Status changed from suspended to discontinued.
    • 29 Nov 2021 According to a Sigilon Therapeutics media release, the company today reported that fibrosed spheres were observed during a retrieval procedure in a patient in this study. All three patients enrolled in the SIG-001 trial will continue to be followed per study protocol.
    • 10 Nov 2021 According to a Sigilon Therapeutics media release, the company expects o provide up to 12 months of follow-up data for three patients from the safety and dose-ranging study of SIG-001 in severe to moderate-severe hemophilia A in the fourth quarter of 2021.

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