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Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

A Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects

NCT00280995•Kastle Therapeutics, LLC

View on ClinicalTrials.gov

Summary

The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as add-on therapy in subjects with Homozygous Familial Hypercholesterolemia

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Weight ≥ 40 kg for Cohorts A, B, \& C; Weight ≥ 50 kg for Cohort D
•Diagnosis of Homozygous Familial Hypercholesterolemia.
•Female must be non-pregnant and non-lactating.
•On stable lipid lowering therapy for at least 4 weeks.
•Lipid values that meet the pre-specified criteria.

Exclusion Criteria

•Subject had heart problems in the prior 6 months.
•Subject has elevated ALT, AST, or CPK.
•History of renal disease, liver disease, or malignancy.
•Use of oral anticoagulants, unless the dose has been stable for 4 weeks
•Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

Locations (6)

Chicago, Illinois, United States

New York, New York, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Houston, Texas, United States

Amsterdam, Netherlands

Key Dates

Start Date

January 1, 2006

Primary Completion Date

April 1, 2007

Completion Date

August 1, 2007

Last Updated

August 3, 2016

Enrollment

ACTUAL participants

Conditions

Hypercholesterolemia, Familial

Interventions

ISIS 301012

DRUG

ISIS 301012

DRUG

ISIS 301012

DRUG

ISIS 301012

DRUG

Screening for Familial Hypercholesterolemia in Children

NCT06555120

Hypercholesterolemia, Familial

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ACTIVE_NOT_RECRUITINGNA

Genetic Testing and Motivational Counseling for FH

NCT04656028

Hypercholesterolemia, FamilialHypercholesterolemia, Familial, 1+24 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

Inclusion Criteria

Exclusion Criteria

Screening for Familial Hypercholesterolemia in Children

Genetic Testing and Motivational Counseling for FH

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