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NCT04125472 Clinical Trial

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

Primary Hyperoxaluria Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04125472
Other study ID # ALN-GO1-006
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date February 2024
Source Alnylam Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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 information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lumasiran
Lumasiran administered as a subcutaneous (SC) injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alnylam Pharmaceuticals
See also
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Completed NCT01037231 - Phase 2/3 Oxabact Study Phase 2/Phase 3
Completed NCT00589225 - Primary Hyperoxaluria Mutation Genotyping Phase 1
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External Links