VALENS: A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT342, an AAV8-Delivered Gene Transfer Therapy in Crigler-Najjar Syndrome Subjects Aged 1 Year and Older

Trial Profile

VALENS: A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT342, an AAV8-Delivered Gene Transfer Therapy in Crigler-Najjar Syndrome Subjects Aged 1 Year and Older

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Oct 2017

At a glance

  • Drugs AT 342 (Primary)
  • Indications Crigler-Najjar syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms VALENS
  • Sponsors Audentes Therapeutics
  • Most Recent Events

    • 12 Sep 2017 Status changed from not yet recruiting to recruiting.
    • 10 Aug 2017 According to an Audentes Therapeutics media release, the company plans to report preliminary clinical data from this study by the end of 2017.
    • 10 Aug 2017 According to an Audentes Therapeutics media release, the company plans to initiate this trial (enroll and dose the first patient) in the third quarter of 2017.
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