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Tests treatment safety and results for Heterozygous or Homozygous Familial Hypercholesterolemia
Official title 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
ClinicalTrials.gov ID: NCT05682378
What this study is testing
What is Inclisiran?
Inclisiran is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for heterozygous or homozygous familial hypercholesterolemia.
Also referred to as KJX839.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 100
You may be able to join if
- Key inclusion:
- Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies
- Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19...
- Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the...
- Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Formosa, Formosa Province, Argentina
- Fortaleza, Ceará, Brazil
- São Paulo, São Paulo, Brazil
- Québec, Quebec, Canada
- Prague, Czechia
- Besançon, France
- Toulouse, France
- Frankfurt am Main, Hesse, Germany
- Freiburg im Breisgau, Germany
- Athens, Greece
- Pécs, Baranya, Hungary
- Jerusalem, Israel
- Ramat Gan, Israel
- Milan, MI, Italy
- Modena, MO, Italy
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States; New York, New York, United States; Cincinnati, Ohio, United States; Pittsburgh, Pennsylvania, United States; Salt Lake City, Utah, United States; Formosa, Formosa Province, Argentina and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.