Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
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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),
Condition or disease
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
6 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Documented diagnosis of Primary Hyperoxaluria Type1
Meet the urine oxalate excretion requirements
Clinically significant health concerns (with the exception of PH1)
An estimated GFR of ≤ 45 mL/min/1.73m2 at screening
Clinically significant abnormal laboratory results at screening
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 renal or liver transplant
Women who are pregnant, planning a pregnancy, or breast-feeding or those of child bearing potential and not willing to use contraception