NCT06597006 - Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

March 21, 2028

Study Completion Date

April 15, 2029

Conditions

Familial Hypercholesterolemia - Homozygous

Interventions

DRUG

Inclisiran

Inclisiran (inclisiran sodium 300 mg subcutaneous (s.c.) for participants with body weight ≥23 kg, inclisiran sodium 180 mg s.c. for participants with body weight \<23 kg to ≥16 kg, or inclisiran sodium 100 mg s.c. for participants with body weight \<16 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 (15)

1090

RECRUITING

Novartis Investigative Site, Vienna

9301

RECRUITING

Novartis Investigative Site, Bloemfontein

16150

RECRUITING

Novartis Investigative Site, Kota Bharu

20010

RECRUITING

Childrens National Hospital, Washington D.C.

35100

RECRUITING

Novartis Investigative Site, Izmir

63110

RECRUITING

Washington Univ School Of Medicine, St Louis

94143

RECRUITING

UC San Francisco Medical Center, San Francisco

RECRUITING

UC San Francisco Medical Center, San Francisco

100029

RECRUITING

Novartis Investigative Site, Beijing

407219

RECRUITING

Novartis Investigative Site, Taichung

455 00

RECRUITING

Novartis Investigative Site, Ioannina

1105 AZ

RECRUITING

Novartis Investigative Site, Amsterdam

01330

RECRUITING

Novartis Investigative Site, Adana

06500

RECRUITING

Novartis Investigative Site, Ankara

SO16 6YD

RECRUITING

Novartis Investigative Site, Southampton