Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1

N/AApproved For MarketingNCT04125472

Alnylam Pharmaceuticals

Overview

The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),

Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Study Type

EXPANDED_ACCESS

Conditions

Primary Hyperoxaluria

Interventions

LumasiranDRUG

Lumasiran administered as a subcutaneous (SC) injection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Documented diagnosis of Primary Hyperoxaluria Type 1 Exclusion Criteria: * Clinically significant health concerns (with the exception of PH1) * Received an investigational agent within 30 days before the first dose of lumasiran or are in follow-up of another clinical study * Previously or currently participating in lumasiran clinical study * History of liver transplant

Data from ClinicalTrials.gov

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