Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
- Conditions
- Primary Hyperoxaluria
- Registration Number
- NCT04125472
- Lead Sponsor
- Alnylam Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method