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NCT00280995 Clinical Trial

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

Hypercholesterolemia, Familial Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00280995
Other study ID # 301012CS8
Secondary ID EudraCT No.: 200
Status Completed
Phase Phase 2
First received January 20, 2006
Last updated August 1, 2016
Start date January 2006
Est. completion date August 2007

Study information
Verified date August 2016
Source Kastle Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationNetherlands: Central Committee on Research Involving Human Subjects
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ISIS 301012
100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
• ISIS 301012
200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
• ISIS 301012
300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85
• ISIS 301012
50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Kastle Therapeutics, LLC Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent reduction in LDL-cholesterol from baseline Week 7 (Cohorts A-C), Week 15 (Cohort D) No
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