NCT05682378 - Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies | Biotech Hunter

Enrollment

125

Participants

Timeline

Start Date

February 10, 2023

Primary Completion Date

March 2, 2028

Study Completion Date

March 2, 2028

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Interventions

DRUG

Inclisiran

Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution administered subcutaneously in pre-filled syringe

Trial Locations (51)

1000

Novartis Investigative Site, Ljubljana

1211

Novartis Investigative Site, Geneva

7130

Novartis Investigative Site, Cape Town

7623

Novartis Investigative Site, Pécs

9301

Novartis Investigative Site, Bloemfontein

10029

Icahn School of Med at Mt Sinai, New York

14004

Novartis Investigative Site, Córdoba

15001

Novartis Investigative Site, A Coruña

15224

Childrens Hosp Pittsburgh UPMC, Pittsburgh

18547

Novartis Investigative Site, Athens

20162

Novartis Investigative Site, Milan

22110

Novartis Investigative Site, Irbid

25030

Novartis Investigative Site, Besançon

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

33011

Novartis Investigative Site, Oviedo

33434

Excel Medical Clinical Trials LLC, Boca Raton

34098

Novartis Investigative Site, Istanbul

35100

Novartis Investigative Site, Izmir

41124

Novartis Investigative Site, Modena

47000

Novartis Investigative Site, Sungai Buloh

59100

Novartis Investigative Site, Kuala Lumpur

60590

Novartis Investigative Site, Frankfurt am Main

79100

Novartis Investigative Site, Freiburg im Breisgau

84113

Primary Childrens Medical Center, Salt Lake City

103616

Novartis Investigative Site, Taipei

127412

Novartis Investigative Site, Moscow

166830

Novartis Investigative Site, El Achrafiyé

650002

Novartis Investigative Site, Kemerovo

5265601

Novartis Investigative Site, Ramat Gan

9112001

Novartis Investigative Site, Jerusalem

60430275

Novartis Investigative Site, Fortaleza

45229-3039

Cincinnati Childrens Hospital MC, Cincinnati

P3600

Novartis Investigative Site, Formosa

04023-900

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

G1V 4W2

Novartis Investigative Site, Québec

128 08

Novartis Investigative Site, Prague

150 06

Novartis Investigative Site, Prague

115 27

Novartis Investigative Site, Athens

00161

Novartis Investigative Site, Roma

00165

Novartis Investigative Site, Roma

3015 GD

Novartis Investigative Site, Rotterdam

1105 AZ

Novartis Investigative Site, Amsterdam

0514

Novartis Investigative Site, Oslo

80 952

Novartis Investigative Site, Gdansk

93-338

Novartis Investigative Site, Lodz

058 01

Novartis Investigative Site, Poprad

01330

Novartis Investigative Site, Adana

06500

Novartis Investigative Site, Ankara

UB9 6JH

Novartis Investigative Site, Middlesex