A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 (ILLUMINATE-A)
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 (ILLUMINATE-A)
The purpose of this study is to evaluate the efficacy and safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 (PH1).
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study With an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Actual Study Start Date: November 27, 2018
Actual Primary Completion Date: November 5, 2019
Estimated Study Completion Date: January 2024
Arms:
- Experimental: Lumasiran (ALN-GO1)
- Placebo Comparator: Sterile Normal Saline (0.9% NaCl)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 39 |
| Actual Study start date | 27 November 2018 |
| Estimated Study Completion Date | 01 January 2024 |