At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
DCR-PHXC +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating DCR-PHXC and Sterile Normal Saline (0.9% NaCl) for Primary Hyperoxaluria Type 1 (PH1) and 4 related conditions. Completed, enrolled 35 participants across 28 sites in 15 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases, Genetic Disease
CountriesAustralia, Canada, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartOct 2019
Primary CompletionJun 2021
Study CompletionJun 2021
TodayJul 2026
First PostedFeb 20, 2019
Enrollment StartOct 28, 2019
Primary CompletionJun 21, 2021
Study CompletionJun 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.4 years ago
Interventions
DCR-PHXCdrug
Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection
Sterile Normal Saline (0.9% NaCl)drug
Sterile Normal Saline (0.9% NaCl) for subcutaneous (SC) injection, administered at same injection volume as DCR-PHXC, to serve as placebo