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Long Term Extension Study in Patients With Primary Hyperoxaluria

NCT04042402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-30

No results posted yet for this study

Summary

The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.

Conditions

  • Primary Hyperoxaluria Type 1 (PH1)
  • Primary Hyperoxaluria Type 2 (PH2)
  • Kidney Diseases
  • Urologic Diseases
  • Genetic Disease
  • Primary Hyperoxaluria Type 3 (PH3)

Interventions

DRUG

DCR-PHXC

Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection

Sponsors & Collaborators

  • Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

    lead INDUSTRY

Principal Investigators

  • Verity Rawson, MB.CHB · Dicerna, A Novo Nordisk Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2030-04-01
Completion
2030-04-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Lebanon
  • Netherlands
  • Norway
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04042402 on ClinicalTrials.gov