Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function (PHYOX8)
Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function (PHYOX8)
ClinicalTrials.gov ID: NCT05001269
Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Information provided by: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company (Responsible Party)
Last Update Posted: 2024-03-28
Brief Summary:
The aim of this study is to evaluate nedosiran in participants 11 years of age and younger who have Primary Hyperoxaluria with relatively intact renal function.
Detailed Description:
This is an open-label, repeat-dose, Phase 2 study of nedosiran in participants 11 years of age or younger who have PH1, PH2 or PH 3 and relatively intact renal function.
Following the up-to-35- day screening period, participants will return to the clinic for monthly dosing visits through Day 180.
The total duration of this study is approximately 15 months from first participant, first visit, until last participant, last visit.
Official Title:
A Phase 2 Open-Label Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Nedosiran in Pediatric Patients From Birth to 11Years of Age With Primary Hyperoxaluria and Relatively Intact Renal Function
Intervention / Treatment:
- Drug: nedosiran
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-02-22
|
| Primary Completion (Estimated) |
2024-12
|
| Study Completion (Estimated) |
2024-12
|
| Enrollment (Estimated) | 25 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
DCR-PHXC-203
|