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
Phase of Trial: Phase I/II
Latest Information Update: 14 Nov 2017
At a glance
- Drugs AT 342 (Primary)
- Indications Crigler-Najjar syndrome
- Focus Adverse reactions; Therapeutic Use
- Acronyms VALENS
- Sponsors Audentes Therapeutics
- 14 Nov 2017 According to an Audentes Therapeutics media release, the company plans to dose first patient in the first quarter of 2018 and to report preliminary data in the second quarter of 2018.
- 13 Nov 2017 According to an Audentes Therapeutics media release, the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Clinical Trial Authorisation (CTA) application for AT342, and it allows Audentes to initiate the enrollment process at clinical sites in the UK.
- 12 Sep 2017 Status changed from not yet recruiting to recruiting.