Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
Public ClinicalTrials.gov record NCT05682378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)
Study identification
- NCT ID
- NCT05682378
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 195 participants
Conditions and interventions
Interventions
- Inclisiran Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 9, 2023
- Primary completion
- Mar 24, 2032
- Completion
- Mar 27, 2032
- Last update posted
- May 14, 2026
2023 – 2032
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | Completed |
| Icahn School of Med at Mt Sinai | New York | New York | 10029 | Active, not recruiting |
| Cincinnati Childrens Hospital MC | Cincinnati | Ohio | 45229-3039 | Completed |
| Childrens Hosp Pittsburgh UPMC | Pittsburgh | Pennsylvania | 15224 | Active, not recruiting |
| Primary Childrens Medical Center | Salt Lake City | Utah | 84113 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05682378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2026 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05682378 live on ClinicalTrials.gov.