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Long Term Extension Study in Patients With Primary Hyperoxaluria
Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
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.
Official title: 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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2019-07-09
Completion Date
2030-04-01
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
DCR-PHXC
Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection
Locations (23)
Clinical Research Site
San Francisco, California, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Rochester, Minnesota, United States
Clinical Trial Site
New York, New York, United States
Clinical Research Site
Herston, Queensland, Australia
Clinical Trial Site
Melbourne, Australia
Clinical Research Site
Hamilton, Ontario, Canada
Clinical Trial Site
Bron, France
Clinical Trial Site
Paris, France
Clinical Trial Site
Bonn, Germany
Clinical Trial Site
Heidelberg, Germany
Clinical Research Site
Roma, Italy
Clinical Trial Site
Fukuoka, Japan
Clinical Trial Site
Nagoya, Japan
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Tokyo, Japan
Clinical Trial Site
Beirut, Lebanon
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Amsterdam, Netherlands
Clinical Trial Site
Tromsø, Norway
Clinical Research Site
Barcelona, Spain
Clinical Trial Site
Barcelona, Spain
Clinical Trial Site
Ankara, Turkey (Türkiye)
Clinical Trial Site
Hampstead, London, United Kingdom
Clinical Trial Site
Birmingham, United Kingdom