NCT03847909

A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

Conditions

• Primary Hyperoxaluria Type 1 (PH1)
• Primary Hyperoxaluria Type 2 (PH2)
• Kidney Diseases
• Urologic Diseases
• Genetic Disease

Interventions

Type	Name	Description
DRUG	DCR-PHXC	Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	Sterile Normal Saline (0.9% NaCl) for subcutaneous (SC) injection, administered at same injection volume as DCR-PHXC, to serve as placebo

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-06-21
• Completion: 2021-06-29
• First posted: 2019-02-20
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

28 sites across 15 countries: United States, Australia, Canada, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study