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The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PH1 | Patients with a diagnosis of PH1 will be eligible for the study and will be managed and treated per routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events in Lumasiran Treated Patients | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Selected Events of Interest in PH1 Patients | Selected events of interest are defined as hepatic events, kidney stones, acute kidney injury events, nephrocalcinosis, chromic kidney disease, kidney failure, and any cardiac, bone, skin, eye, hematological, or neuropathic manifestations due to oxalosis. | Up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with PH1 will be managed and treated per routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Phoenix | Arizona | 85016 | United States | ||
| Clinical Trial Site |
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| 12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version) |
SF-12 V2 is a 12-question measure capturing global quality of life and overall health status and evaluates the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. |
| Up to 7 years |
| Change in Urinary Oxalate Excretion | Baseline and every 12 months for up to 7 years |
| Change in Plasma Oxalate | Baseline and every 12 months for up to 7 years |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Clinical Trial Site | Boston | Massachusetts | 02115 | United States |
| Clinical Trial Site | Rochester | Minnesota | 55905 | United States |
| Clinical Trial Site | Cincinnati | Ohio | 45229 | United States |
| Clinical Trial Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Trial Site | Dallas | Texas | 75390 | United States |
| Clinical Trial Site | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Ghent | Belgium |
| Clinical Trial Site | Liège | Belgium |
| Clinical Trial Site | Hamilton | Ontario | Canada |
| Clinical Trial Site | Toronto | Ontario | Canada |
| Clinical Trial Site | Laurier | Quebec | Canada |
| Clinical Trial Site | Bordeaux | France |
| Clinical Trial Site | Lyon | France |
| Clinical Trial Site | Paris | France |
| Clinical Trial Site | Berlin | Germany |
| Clinical Trial Site | Cologne | Germany |
| Clinical Trial Site | Hamburg | Germany |
| Clinical Trial Site | Jerusalem | Israel |
| Clinical Trial Site | Orbassano | Torino | Italy |
| Clinical Trial Site | Milan | Italy |
| Clinical Trial Site | Verona | Italy |
| Clinical Trial Site | Amsterdam | Netherlands |
| Clinical Trial Site | Santa Cruz de Tenerife | Canary Islands | Spain |
| Clinical Trial Site | Barcelona | Spain |
| Clinical Trial Site | Las Palmas | Spain |
| Clinical Trial Site | Bern | Switzerland |
| Clinical Trial Site | London | England | United Kingdom |
| Clinical Trial Site | London | United Kingdom |
| ID | Term |
|---|---|
| C536414 | Primary hyperoxaluria type 1 |
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