An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Patients With Primary Hyperoxaluria Type 1

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in patients with Primary Hyperoxaluria Type 1.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Enrollment within 12 months of completion of Study ALN-GO1-001

• In the opinion of the investigator tolerated the study drug

• If taking Vitamin B6 (pyridoxine), willing to remain on a stable regimen for the study duration

• Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception

• Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

• Clinically significant health concerns (with the exception of PH1)

• Clinically significant cardiovascular abnormality

• Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant

• Requirement for chronic dialysis