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

NCT00280995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-03

No results posted yet for this study

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

Conditions

  • Hypercholesterolemia, Familial

Interventions

DRUG

ISIS 301012

100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

DRUG

ISIS 301012

200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

DRUG

ISIS 301012

300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85

DRUG

ISIS 301012

50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Kastle Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-04-30
Completion
2007-08-31

Countries

  • United States
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00280995 on ClinicalTrials.gov