Basic Information

Gene symbol APOB Synonyms FCHL2, FLDB, LDLCQ4, apoB-100, apoB-48 Type of gene protein-coding
Gene perturbation-related omics dataset PertOrg
Description apolipoprotein B

GTO ID GTC0072
Trial ID NCT00794664
Disease Familial Hypercholesterolemia | Coronary Artery Disease
Altered gene APOB
Therapeutic/Target gene Target gene
TherapyASO
Treatment ISIS 301012|mipomersen sodium|Kynamro
Location approved US, Mexico, Argentina, South Korea
PhasePhase3
Recruitment statusCompleted
TitleA 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 Regimen and Who Are Not on Apheresis
Year2009
CountryCanada|Czech Republic|Germany|South Africa|United Kingdom|United States
Company sponsorKastle Therapeutics, LLC
Other ID(s)MIPO3500108|2008-006020-53
Vector information
VectorNo vector was used

Clinical Result

Cohort1: Placebo
Administration route subcutaneous injection
Pts 58
Age Adult, Older_Adult
Outcome Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point:Mean (Standard Deviation):12.5(46.87)|LDL-C at Baseline and the Primary Efficacy Time Point (PET):Baseline Mean (Standard Deviation):249.4(84.3); PET:263.9(102.0)
Adverse reactions No serious clinical adverse events
References PMID: 25614280
Cohort2: mipomersen
Administration route subcutaneous injection
Dosage mipomersen, 200 mg, weekly for 26 weeks
Pts 58
Age Adult, Older_Adult
Outcome Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point:Mean (Standard Deviation):-35.9(24.71)|LDL-C at Baseline and the Primary Efficacy Time Point (PET):Baseline Mean (Standard Deviation):276.1(72.1); PET:174.9(82.8)
Adverse reactions 6/39(Cardiac disorders; General disorders; Hepatobiliary disorders)
References PMID: 25614280

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