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A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

NCT03681184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-08-12

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).

Conditions

  • Primary Hyperoxaluria Type 1 (PH1)

Interventions

DRUG

Placebo

Placebo by SC injection

DRUG

Lumasiran

Lumasiran by SC injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2019-11-05
Completion
2024-01-12
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • Netherlands
  • Switzerland
  • United Arab Emirates
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03681184 on ClinicalTrials.gov