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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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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.

Conditions

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Primary Hyperoxaluria

Interventions

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Lumasiran

Lumasiran administered as a subcutaneous (SC) injection

Intervention Type DRUG

Other Intervention Names

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ALN-GO1

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No