MedTrace Logo

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

NCT03847909 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-05-22

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2021-06-21
Completion
2021-06-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847909 on ClinicalTrials.gov