ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
Who is this study for? Children under 5 with primary hyperoxaluria type 1
What treatments are being studied? Lumasiran
Status: Completed
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).
Eligibility
Participation Requirements
Sex: All
Maximum Age: 5
Healthy Volunteers: f
View:
• Has genetic confirmation of primary hyperoxaluria type 1 (PH1)
• Meets urinary oxalate excretion requirements
• If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days
Locations
United States
Minnesota
Clinical Trial Site
Rochester
Texas
Clinical Trial Site
Houston
Other Locations
France
Clinical Trial Site
Lyon
Clinical Trial Site
Paris
Germany
Clinical Trial Site
Bonn
Israel
Clinical Trial Site
Haifa
Clinical Trial Site
Jerusalem
Clinical Trial Site
Nahariya
United Kingdom
Clinical Trial Site
London
Time Frame
Start Date: 2019-04-22
Completion Date: 2024-07-26
Participants
Target number of participants: 18
Treatments
Experimental: Lumasiran
Lumasiran will be administered by subcutaneous (SC) injection.
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals