NCT00280995

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-04-01
• Completion: 2007-08-01
• First posted: 2006-01-24
• Last updated: 2016-08-03

Locations

6 sites across 2 countries: United States, Netherlands