Trial Profile
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
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 19 Apr 2024
Price :
$35
*
At a glance
- Drugs Nedosiran (Primary)
- Indications Primary hyperoxaluria
- Focus Therapeutic Use
- Acronyms PHYOX 3
- Sponsors Dicerna Pharmaceuticals; Novo Nordisk
- 02 Oct 2023 According to Novo Nordisk media release, U.S. FDA has approved RivflozaTM for children 9 years of age and older and adults living with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. This approval is based on interim data of this trial and results of phase 2 PHYOXTM2 trial.
- 27 Jul 2023 Planned End Date changed from 1 Jul 2027 to 1 Apr 2030.
- 27 Jul 2023 Planned primary completion date changed from 1 Jul 2027 to 1 Apr 2030.