المصدر: An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Adolescent ORION-16 or ORION-13 Studies (VICTORION-PEDS-OLE)

المصدر: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-16)
Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.
Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

المصدر: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)
Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.
Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

المصدر: Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)

المصدر: Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH)

المصدر: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children (6 to Less Than 12 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL- Cholesterol

المصدر: Open-label, Phase 1b, Single-ascending Dose and Optional Re Dosing Study to Evaluate the Safety of VERVE-101 Administered to Patients with Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, and Uncontrolled Hypercholesterolemia

المساهمون: Gregory Piazza, MD, MS, Staff Physician

المصدر: Alert-Based Computerized Decision Support for Identification and Management of Patients with Familial Hypercholesterolemia (FH-ALERT Trial)

المؤلفون: Moscow State University of Medicine and Dentistry

المصدر: Impact of Genetic Testing and Motivational Counseling on the Adherence to Healthy Lifestyle and Hypolipidemic Therapy and Efficiency of Cascade Screening in Patients With Familial Hypercholesterolemia (GENMOTIV-FH)

المؤلفون: National Heart, Lung, and Blood Institute (NHLBI)

المساهمون: MacRae F. Linton, MD, Professor of Medicine and Pharmacology

المصدر: 2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

المؤلفون: University of Sao Paulo, National Institute of Cardiology, Laranjeiras, Brazil, Instituto Dante Pazzanese de Cardiologia

المصدر: Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not with Phytosterols And/or Krill Oil in Patients with Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial

المصدر: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

المؤلفون: University of Amsterdam, University of Cape Town, University of Witwatersrand, South Africa

المصدر: HoFH, the International Clinical Collaborators - A Global HoFH Data-sharing Platform
Tromp TR, Hartgers ML, Hovingh GK, Vallejo-Vaz AJ, Ray KK, Soran H, Freiberger T, Bertolini S, Harada-Shiba M, Blom DJ, Raal FJ, Cuchel M; Homozygous Familial Hypercholesterolaemia International Clinical Collaborators. Worldwide experience of homozygous familial hypercholesterolaemia: retrospective cohort study. Lancet. 2022 Feb 19;399(10326):719-728. doi: 10.1016/S0140-6736(21)02001-8. Epub 2022 Jan 28.

المصدر: A Clinical Study for the Safety and Efficacy of Intravenous Infusion of NGGT006 in Treatment of Homozygous Familial Hypercholesterolemia With LDLR Mutations

المصدر: A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 Injection in Chinese Adolescents and Adults with Homozygous Familial Hypercholesterolaemia (HoFH)

المصدر: Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants with or At High Risk for Cardiovascular Disease

المساهمون: Lars Karlsson, Senior Consultant, Principal investigator

المصدر: Clinical Decision Support for Familial Hypercholesterolemia: a Cluster Randomized Trial in the Primary Care Setting

المصدر: Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan

Other URLs: https://www.amgen.com/datasharing

المصدر: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Children (2 to Less Than 12 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol