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Clinical trials for LDL apheresis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    20 result(s) found for: LDL apheresis. Displaying page 1 of 1.
    EudraCT Number: 2016-002983-16 Sponsor Protocol Number: EVOLAFER01 Start Date*: 2017-05-03
    Sponsor Name:SERVICIO DE NEFROLOGIA
    Full Title: PILOT STUDY TO COMPARE THE EFFICACY OF EVOLOCUMAB VS LDL-APHERESIS IN PATIENTS WITH HYPERCHOLESTEROLEMIA
    Medical condition: FAMILIAR HYPERCHOLESTEROLEMIA
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002539-24 Sponsor Protocol Number: MICA Start Date*: 2012-05-03
    Sponsor Name:Hospital of the University of Munich
    Full Title: Effect of Mipomersen on LDL-Cholesterol Levels in Patients with Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis
    Medical condition: In this trial, the effect of mipomersen is tested on LDL-cholesterol levels in patients with severe LDL-hypercholesterolemia and atherosclerosis which are regularly treated by LDL-apheresis.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10027424 Metabolic and nutritional disorders congenital HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001917-20 Sponsor Protocol Number: R727-CL-1216.03 Start Date*: 2015-02-27
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia Undergoing Lipid A...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003059-41 Sponsor Protocol Number: CTQJ230A12302 Start Date*: 2022-06-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo-controlled, multicenter trial assessing the reduction of the rate of lipoprotein apheresis after treatment with pelacarsen (TQJ230) compared to placebo in patien...
    Medical condition: Cardiovascular Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10051614 Arteriosclerotic cardiovascular disease LLT
    21.1 10042613 - Surgical and medical procedures 10061653 Apheresis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002297-39 Sponsor Protocol Number: EFC14660 Start Date*: 2018-09-19
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) FR (Completed) NL (Completed) IT (Completed) DK (Completed) AT (Completed) SI (Completed) ES (Completed) BG (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001343-37 Sponsor Protocol Number: 20140316 Start Date*: 2015-12-18
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evo...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001388-19 Sponsor Protocol Number: R1500-CL-1629 Start Date*: 2018-06-18
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia
    Medical condition: Homozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Ongoing) AT (Completed) CZ (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005400-15 Sponsor Protocol Number: 20110271 Start Date*: 2012-03-22
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia
    Medical condition: Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012386 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GR (Completed) CZ (Completed) GB (Completed) ES (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002434-37 Sponsor Protocol Number: MK0859-042 Start Date*: 2013-05-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Pa...
    Medical condition: Homozygous Familial Hypercholesterolemia (HoFH)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NO (Prematurely Ended) CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004496-39 Sponsor Protocol Number: RGX-501-102 Start Date*: 2020-08-12
    Sponsor Name:REGENXBIO Inc.
    Full Title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501
    Medical condition: Adults with homozygous familial hypercholesterolemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006020-53 Sponsor Protocol Number: MIPO3500108 Start Date*: 2009-04-08
    Sponsor Name:Genzyme Europe B.V.
    Full Title: A Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering...
    Medical condition: Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who are Not on Apheresis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020603 Hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000972-24 Sponsor Protocol Number: D3561C00004 Start Date*: 2014-08-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10054380 Familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) BE (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001446-25 Sponsor Protocol Number: FHGT002 Start Date*: 2017-09-20
    Sponsor Name:University of Pennsylvania
    Full Title: AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Adults with homozygous familial hypercholesterolemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007058-36 Sponsor Protocol Number: 733-005 Start Date*: 2009-06-25
    Sponsor Name:Aegerion Pharmaceuticals
    Full Title: A Phase III Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor AEGR-733 in Patients with Homozygous Familial Hypercholesterolemia on Current Lipid-lowering Therapy
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10048373 Hypercholesterolaemia aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004856-68 Sponsor Protocol Number: CB8025-21427 Start Date*: 2015-04-29
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003806-33 Sponsor Protocol Number: AEGR-733-020 Start Date*: 2016-06-30
    Sponsor Name:Aegerion Pharmaceuticals Inc.
    Full Title: A Phase 3, Single-arm, Open-label, International, Multi-center Study to Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients with Homozygous Familial Hypercholesterolemia on Stable ...
    Medical condition: Homozygous familial hypercholesterolemia (HoFH).
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002278-30 Sponsor Protocol Number: APH-19 Start Date*: 2020-08-12
    Sponsor Name:Amryt Pharmaceuticals DAC
    Full Title: Phase III, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with Homozygous Familial Hypercholesterolaemia (HoFH) o...
    Medical condition: Homozygous familial hypercholesterolaemia (HoFH). A rare and life-threatening inherited disorder of lipid metabolism with an estimated prevalence of 1 per 160,000 to 300,000 in the European populat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004394-49 Sponsor Protocol Number: LIB003-007 Start Date*: 2021-08-12
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at ...
    Medical condition: Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004287-30 Sponsor Protocol Number: LAL-CL06 Start Date*: 2014-06-19
    Sponsor Name:Alexion Pharmaceuticals inc
    Full Title: A Multicenter, Open-Label Study of Sebelipase Alfa in Patients with Lysosomal Acid Lipase Deficiency
    Medical condition: Lysosomal Acid Lipase Deficiency (LALD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10024579 Lysosomal storage disorders HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) ES (Completed) GB (Completed) IT (Prematurely Ended) DE (Completed) BE (Completed) HR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000687-30 Sponsor Protocol Number: AROAPOC3-2001 Start Date*: 2021-10-04
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Severe Hypertriglyceridemia
    Medical condition: Severe Hypertriglyceridemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) NL (Completed) PL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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