Trials / Active Not Recruiting
Active Not RecruitingNCT04042402
Long Term Extension Study in Patients With Primary Hyperoxaluria
An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | DCR-PHXC | Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection |
Timeline
- Start date
- 2019-07-09
- Primary completion
- 2030-04-01
- Completion
- 2030-04-01
- First posted
- 2019-08-02
- Last updated
- 2025-05-30
Locations
23 sites across 13 countries: United States, Australia, Canada, France, Germany, Italy, Japan, Lebanon, Netherlands, Norway, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04042402. Inclusion in this directory is not an endorsement.