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A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1

NCT04152200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-18

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 patients with Advanced Primary Hyperoxaluria Type 1 (PH1).

Conditions

  • Primary Hyperoxaluria Type 1
  • Primary Hyperoxaluria

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

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2021-05-18
Completion
2025-06-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Israel
  • Italy
  • Jordan
  • Lebanon
  • Netherlands
  • Turkey (Türkiye)
  • United Arab Emirates

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 NCT04152200 on ClinicalTrials.gov