Back to Trials
NCT05682378PHASE3Recruiting

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

Novartis Pharmaceuticals

Start Date

2/10/2023

Completion Date

3/28/2032

Summary

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.

Detailed Description

This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.

Eligibility Criteria

Age Range: 12 years to 100 years

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 studies Key exclusion: * Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment * Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk

Interventions

DRUG

Inclisiran

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Locations

Excel Medical Clinical Trials LLC

Boca Raton, Florida 33434

United States

Icahn School of Med at Mt Sinai

New York, New York 10029

United States

Cincinnati Childrens Hospital MC

Cincinnati, Ohio 45229-3039

United States

Childrens Hosp Pittsburgh UPMC

Pittsburgh, Pennsylvania 15224

United States

Primary Childrens Medical Center

Salt Lake City, Utah 84113

United States

Novartis Investigative Site

Formosa, Formosa Province P3600

Argentina

Novartis Investigative Site

Fortaleza, Ceará 60430-275

Brazil

Novartis Investigative Site

São Paulo, São Paulo 04023-900

Brazil

Novartis Investigative Site

São Paulo, São Paulo 05403 000

Brazil

Novartis Investigative Site

Québec, Quebec G1V 4W2

Canada

Novartis Investigative Site

Prague, 128 08

Czechia

Novartis Investigative Site

Prague, 150 06

Czechia

Novartis Investigative Site

Besançon, 25030

France

Novartis Investigative Site

Toulouse, 31059

France

Novartis Investigative Site

Frankfurt am Main, Hesse 60590

Germany

Novartis Investigative Site

Freiburg im Breisgau, 79100

Germany

Novartis Investigative Site

Athens, 115 27

Greece

Novartis Investigative Site

Athens, 185 47

Greece

Novartis Investigative Site

Pécs, Baranya 7623

Hungary

Novartis Investigative Site

Jerusalem, 9112001

Israel

Novartis Investigative Site

Ramat Gan, 5265601

Israel

Novartis Investigative Site

Milan, MI 20162

Italy

Novartis Investigative Site

Modena, MO 41124

Italy

Novartis Investigative Site

Roma, RM 00161

Italy

Novartis Investigative Site

Roma, RM 00165

Italy

Novartis Investigative Site

Irbid, 22110

Jordan

Novartis Investigative Site

Beirut, 113-0236

Lebanon

Novartis Investigative Site

Beirut, 166830

Lebanon

Novartis Investigative Site

Sungai Buloh, Selangor 47000

Malaysia

Novartis Investigative Site

Kuala Lumpur, 59100

Malaysia

Novartis Investigative Site

Amsterdam, North Holland 1105 AZ

Netherlands

Novartis Investigative Site

Rotterdam, South Holland 3015 GD

Netherlands

Novartis Investigative Site

Oslo, 0514

Norway

Novartis Investigative Site

Gdansk, 80 952

Poland

Novartis Investigative Site

Lodz, Łódź Voivodeship 93-338

Poland

Novartis Investigative Site

Kemerovo, 650002

Russia

Novartis Investigative Site

Moscow, 127412

Russia

Novartis Investigative Site

Poprad, 058 01

Slovakia

Novartis Investigative Site

Ljubljana, 1000

Slovenia

Novartis Investigative Site

Bloemfontein, Free State 9301

South Africa

Novartis Investigative Site

Cape Town, Western Cape 7130

South Africa

Novartis Investigative Site

Pamplona, Navarre 31008

Spain

Novartis Investigative Site

Oviedo, Principality of Asturias 33011

Spain

Novartis Investigative Site

A Coruña, 15001

Spain

Novartis Investigative Site

Córdoba, 14004

Spain

Novartis Investigative Site

Geneva, 1211

Switzerland

Novartis Investigative Site

Taipei, 111045

Taiwan

Novartis Investigative Site

Istanbul, Fatih 34098

Turkey (Türkiye)

Novartis Investigative Site

Adana, Saricam 01330

Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle 06500

Turkey (Türkiye)

Novartis Investigative Site

Izmir, 35100

Turkey (Türkiye)

Novartis Investigative Site

Middlesex, UB9 6JH

United Kingdom