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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04125472
Enrollment
Unknown
Registered
2019-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hyperoxaluria

Keywords

Hyperoxaluria, Primary Hyperoxaluria, Kidney Diseases, Urologic Diseases, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases, RNA Therapeutic, siRNA

Brief summary

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

Detailed description

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.

Interventions

DRUGLumasiran

Lumasiran administered as a subcutaneous (SC) injection

Sponsors

Alnylam Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026