NCT03905694

A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 5 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Hyperoxaluria
• Primary Hyperoxaluria Type 1 (PH1)

Interventions

Type	Name	Description
DRUG	Lumasiran	Lumasiran will be administered by subcutaneous (SC) injection.

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-06-29
• Completion: 2024-07-26
• First posted: 2019-04-05
• Last updated: 2025-02-14
• Results posted: 2021-07-19

Locations

9 sites across 5 countries: United States, France, Germany, Israel, United Kingdom

Regulatory

• FDA-regulated drug study