Status:

APPROVED_FOR_MARKETING

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

Lead Sponsor:

Alnylam Pharmaceuticals

Conditions:

Primary Hyperoxaluria

Eligibility:

All Genders

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 abou...

Eligibility Criteria

Inclusion

  • Documented diagnosis of Primary Hyperoxaluria Type 1

Exclusion

  • 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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04125472

Last Update

February 16 2024

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