Status:
COMPLETED
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
PH1
Primary Hyperoxaluria
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03350451
Start Date
April 4 2018
End Date
February 7 2023
Last Update
April 25 2024
Active Locations (9)
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1
Clinical Trial Site
Bordeaux, France
2
Clinical Trial Site
Lyon, France
3
Clinical Trial Site
Paris, France
4
Clinical Trial Site
Bonn, Germany