An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary … (NCT03350451) | Clinical Trial Compass
CompletedPhase 2
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1
France, Germany, Israel20 participantsStarted 2018-04-04
Plain-language summary
The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.
Who can participate
Age range6 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants With at Least One Adverse Event (AE)