A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 (ILLUMINATE-B)
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 (ILLUMINATE-B)
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).
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 22, 2019
Actual Primary Completion Date: June 29, 2020
Estimated Study Completion Date: August 19, 2024
Arm:
- Experimental: Lumasiran
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 18 |
| Actual Study start date | 22 April 2019 |
| Estimated Study Completion Date | 19 August 2024 |