A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 (PHYOX2)
A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 (PHYOX2)
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)
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: October 28, 2019
Estimated Primary Completion Date: October 2020
Estimated Study Completion Date: May 2021
Arm:
- Experimental: DCR-PHXC
- Placebo Comparator: Placebo - Sterile Normal Saline (0.9% NaCl)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 36 |
| Actual Study start date | 28 October 2019 |
| Estimated Study Completion Date | 01 May 2021 |