PHYOX 3

• Research type

  Research Study

• Full title

  An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

• IRAS ID

  255292

• Contact name

  Shabbir Moochhala

• Contact email

  smoochhala@nhs.net

• Sponsor organisation

  Dicerna Pharmaceuticals, Inc.

• Eudract number

  2018-003099-10

• Clinicaltrials.gov Identifier

  132214, IND Number

• Duration of Study in the UK

  3 years, 3 months, 0 days

• Research summary

  The primary objective of this study is to evaluate the safety and tolerability of DCR-PHXC when given monthly to patients with primary hyperoxaluria (PH). Participants will be recruited into this study from previous phase 1 and 2 studies of DCR-PHXC to determine the long term safety and efficacy of DCR-PHXC in PH patients

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0023

• Date of REC Opinion

  1 Mar 2019

• REC opinion

  Further Information Favourable Opinion