A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Completed · Phase 3 · Has a placebo group
Conditions studied: Primary Hyperoxaluria Type 1 (PH1)
In brief
The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).
Key facts
- Study ID
- NCT03681184
- Run by
- Alnylam Pharmaceuticals
- People needed
- 39
- Starts
- 2018-11-27
- Expected to finish
- 2024-01-12
- Last updated by the study team
- 2024-08-12
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing to provide written informed consent or assent and to comply with study requirements
- Confirmation of PH1 disease
- Meet the 24 hour urine oxalate excretion requirements
- If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days
You may not qualify if…
- Clinically significant health concerns (with the exception of PH1) or clinical evidence of extrarenal systemic oxalosis
- Clinically significant abnormal laboratory results
- Known active or evidence of HIV or hepatitis B or C infection
- An estimated GFR of < 30 mL/min/1.73m\^2 at screening
- Received an investigational agent within 30 days or 5 half-lives before the first dose of study drug or are in follow-up of another clinical study
- History of kidney or liver transplant
- Known history of multiple drug allergies or allergic reaction to an oligonucleotide or GalNAc
- History of intolerance to subcutaneous injection
- Women who are pregnant, planning a pregnancy, or breast-feeding or those of child bearing potential and not willing to use contraception
- History of alcohol abuse within the last 12 months, or unable or unwilling to limit alcohol consumption throughout the study
Where it is running
- Clinical Trial Site — San Diego, California, United States
- Clinical Trial Site — Jacksonville, Florida, United States
- Clinical Trial Site — Rochester, Minnesota, United States
- Clinical Trial Site — New York, New York, United States
- Clinical Trial Site — Cleveland, Ohio, United States
- Clinical Trial Site — Lyon, France
- Clinical Trial Site — Paris, France
- Clinical Trial Site — Bonn, Germany
- Clinical Trial Site — Haifa, Israel
- Clinical Trial Site — Jerusalem, Israel
- Clinical Trial Site — Nahariya, Israel
- Clinical Trial Site — Amsterdam, Netherlands
- Clinical Trial Site — Bern, Switzerland
- Clinical Trial Site — Dubai, United Arab Emirates
- Clinical Trial Site — Birmingham, United Kingdom
- Clinical Trial Site — London, United Kingdom
- Clinical Trial Site — London, United Kingdom
Full record on ClinicalTrials.gov
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