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

NCT03905694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-14

Study results available
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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

DRUG

Lumasiran

Lumasiran will be administered by subcutaneous (SC) injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-06-29
Completion
2024-07-26
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905694 on ClinicalTrials.gov