NCT06597019 - Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 9, 2024

Primary Completion Date

March 21, 2028

Study Completion Date

April 15, 2029

Conditions

Familial Hypercholesterolemia - Heterozygous

Interventions

DRUG

Inclisiran

Inclisiran (inclisiran sodium 300 mg subcutaneous (s.c.) for participants with body weight ≥23 kg and inclisiran sodium 180 mg s.c. for participants with body weight \<23 kg. The dose level is based on the participant's body weight on Day 1 (for Part 1) and Day 360 (for Part 2), respectively.

DRUG

Placebo

Sterile normal saline (0.9% sodium chloride in water for subcutaneous injection)

Trial Locations (55)

1026

RECRUITING

Novartis Investigative Site, Budapest

1090

RECRUITING

Novartis Investigative Site, Vienna

1200

RECRUITING

Novartis Investigative Site, Brussels

3000

RECRUITING

Novartis Investigative Site, Leuven

3712

RECRUITING

Novartis Investigative Site, Verona

5020

RECRUITING

Novartis Investigative Site, Salzburg

9301

RECRUITING

Novartis Investigative Site, Bloemfontein

10029

RECRUITING

Icahn School of Med at Mt Sinai, New York

10126

RECRUITING

Novartis Investigative Site, Torino

11009

RECRUITING

Novartis Investigative Site, Cadiz

11217

RECRUITING

Novartis Investigative Site, Taipei

13885

RECRUITING

Novartis Investigative Site, Marseille

20010

NOT_YET_RECRUITING

Children's National Hospital, Washington D.C.

RECRUITING

Childrens National Hospital, Washington D.C.

20162

RECRUITING

Novartis Investigative Site, Milan

26506

RECRUITING

West Virginia Childrens Hospital, Morgantown

29010

RECRUITING

Novartis Investigative Site, Málaga

30173

RECRUITING

Novartis Investigative Site, Hanover

31008

RECRUITING

Novartis Investigative Site, Pamplona

33434

RECRUITING

Excel Medical Clinical Trials LLC, Boca Raton

35100

RECRUITING

Novartis Investigative Site, Izmir

41013

RECRUITING

Novartis Investigative Site, Seville

44093

RECRUITING

Novartis Investigative Site, Nantes

50586

RECRUITING

Novartis Investigative Site, Kuala Lumpur

75571

RECRUITING

Novartis Investigative Site, Paris

79106

RECRUITING

Novartis Investigative Site, Freiburg im Breisgau

84113

NOT_YET_RECRUITING

Primary Childrens Medical Center, Salt Lake City

94143

RECRUITING

UC San Francisco Medical Center, San Francisco

100029

RECRUITING

Novartis Investigative Site, Beijing

103616

RECRUITING

Novartis Investigative Site, Taipei

200127

RECRUITING

Novartis Investigative Site, Shanghai

999077

RECRUITING

Novartis Investigative Site, Hong Kong

5265601

RECRUITING

Novartis Investigative Site, Ramat Gan

9112001

RECRUITING

Novartis Investigative Site, Jerusalem

60430275

RECRUITING

Novartis Investigative Site, Fortaleza

C1181ACH

RECRUITING

Novartis Investigative Site, CABA

20211-340

RECRUITING

Novartis Investigative Site, Rio de Janeiro

90020-020

RECRUITING

Novartis Investigative Site, Porto Alegre

05403 000

RECRUITING

Novartis Investigative Site, São Paulo

128 08

RECRUITING

Novartis Investigative Site, Prague

150 06

RECRUITING

Novartis Investigative Site, Prague

455 00

RECRUITING

Novartis Investigative Site, Ioannina

115 27

RECRUITING

Novartis Investigative Site, Athens

00165

RECRUITING

Novartis Investigative Site, Roma

1105 AZ

RECRUITING

Novartis Investigative Site, Amsterdam

15-274

RECRUITING

Novartis Investigative Site, Bialystok

80 952

RECRUITING

Novartis Investigative Site, Gdansk

93-338

RECRUITING

Novartis Investigative Site, Lodz

1649 035

RECRUITING

Novartis Investigative Site, Lisbon

4200 319

RECRUITING

Novartis Investigative Site, Porto

03203

RECRUITING

Novartis Investigative Site, Elche

08041

RECRUITING

Novartis Investigative Site, Barcelona

01330

RECRUITING

Novartis Investigative Site, Adana

06500

RECRUITING

Novartis Investigative Site, Ankara

B4 6NH

RECRUITING

Novartis Investigative Site, West Midlands