Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-01
195
Participants Needed
52
Research Sites
476 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies
- Participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies as judged by investigator
You will not qualify if you...
- Participants who screen failed or permanently discontinued treatment or study in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies
- Serious safety or tolerability issues related to inclisiran treatment in previous studies
- Any uncontrolled or serious disease or medical, physical, or surgical condition that may interfere with participation or put the participant at significant risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
Completed
2
Icahn School of Med at Mt Sinai
New York, New York, United States, 10029
Active, Not Recruiting
3
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, United States, 45229-3039
Completed
4
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States, 15224
Active, Not Recruiting
5
Primary Childrens Medical Center
Salt Lake City, Utah, United States, 84113
Completed
6
Novartis Investigative Site
Formosa, Formosa Province, Argentina, P3600
Active, Not Recruiting
7
Novartis Investigative Site
Fortaleza, Ceará, Brazil, 60430-275
Active, Not Recruiting
8
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04023-900
Completed
9
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Active, Not Recruiting
10
Novartis Investigative Site
Québec, Quebec, Canada, G1V 4W2
Active, Not Recruiting
11
Novartis Investigative Site
Prague, Czechia, 128 08
Active, Not Recruiting
12
Novartis Investigative Site
Prague, Czechia, 150 06
Actively Recruiting
13
Novartis Investigative Site
Besançon, France, 25030
Active, Not Recruiting
14
Novartis Investigative Site
Toulouse, France, 31059
Active, Not Recruiting
15
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590
Active, Not Recruiting
16
Novartis Investigative Site
Freiburg im Breisgau, Germany, 79100
Completed
17
Novartis Investigative Site
Athens, Greece, 115 27
Completed
18
Novartis Investigative Site
Athens, Greece, 185 47
Active, Not Recruiting
19
Novartis Investigative Site
Pécs, Baranya, Hungary, 7623
Completed
20
Novartis Investigative Site
Jerusalem, Israel, 9112001
Active, Not Recruiting
21
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Active, Not Recruiting
22
Novartis Investigative Site
Milan, MI, Italy, 20162
Completed
23
Novartis Investigative Site
Modena, MO, Italy, 41124
Completed
24
Novartis Investigative Site
Roma, RM, Italy, 00161
Completed
25
Novartis Investigative Site
Roma, Italy, 165
Active, Not Recruiting
26
Novartis Investigative Site
Irbid, Jordan, 22110
Active, Not Recruiting
27
Novartis Investigative Site
Beirut, Lebanon, 113-0236
Active, Not Recruiting
28
Novartis Investigative Site
Beirut, Lebanon, 166830
Active, Not Recruiting
29
Novartis Investigative Site
Sungai Buloh, Selangor, Malaysia, 47000
Active, Not Recruiting
30
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Active, Not Recruiting
31
Novartis Investigative Site
Amsterdam, North Holland, Netherlands, 1105 AZ
Active, Not Recruiting
32
Novartis Investigative Site
Rotterdam, South Holland, Netherlands, 3015 GD
Active, Not Recruiting
33
Novartis Investigative Site
Oslo, Norway, 0514
Active, Not Recruiting
34
Novartis Investigative Site
Gdansk, Poland, 80 952
Active, Not Recruiting
35
Novartis Investigative Site
Lodz, Łódź Voivodeship, Poland, 93-338
Completed
36
Novartis Investigative Site
Kemerovo, Russia, 650002
Completed
37
Novartis Investigative Site
Moscow, Russia, 127412
Completed
38
Novartis Investigative Site
Poprad, Slovakia, 058 01
Active, Not Recruiting
39
Novartis Investigative Site
Ljubljana, Slovenia, 1000
Active, Not Recruiting
40
Novartis Investigative Site
Bloemfontein, Free State, South Africa, 9301
Completed
41
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7130
Completed
42
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Active, Not Recruiting
43
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain, 33011
Completed
44
Novartis Investigative Site
A Coruña, Spain, 15001
Completed
45
Novartis Investigative Site
Córdoba, Spain, 14004
Active, Not Recruiting
46
Novartis Investigative Site
Geneva, Switzerland, 1211
Active, Not Recruiting
47
Novartis Investigative Site
Taipei, Taiwan, 111045
Active, Not Recruiting
48
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34098
Active, Not Recruiting
49
Novartis Investigative Site
Adana, Saricam, Turkey (Türkiye), 01330
Active, Not Recruiting
50
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Active, Not Recruiting
51
Novartis Investigative Site
Izmir, Turkey (Türkiye), 35100
Active, Not Recruiting
52
Novartis Investigative Site
Middlesex, United Kingdom, UB9 6JH
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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