An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Lipid Metabolism, Inborn ErrorsHypercholesterolemia, Autosomal DominantHyperlipidemiasMetabolic DiseasesHyperlipoproteinemia Type IIMetabolism, Inborn ErrorsGenetic Diseases, InbornInfant, Newborn, DiseasesMetabolic DisorderCongenital AbnormalitiesHypercholesterolemiaHyperlipoproteinemiasDyslipidemiasLipid Metabolism Disorders
Interventions
DRUG

Mipomersen Sodium

Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.

Trial Locations (33)

2193

Parktown

7925

Observatory

10032

New York

11217

Taipei

27710

Durham

28204

Charlotte

32792

Winter Park

32901

Melbourne

37232

Nashville

45005

Franklin

45212

Cincinnati

60654

Chicago

63110

St Louis

66160

Kansas City

75226

Dallas

92660

Newport Beach

92691

Mission Viejo

97239

Portland

98104

Seattle

168752

Singapore

06606

Bridgeport

04005

Biddeford

02114

Boston

03301

Concord

Unknown

São Paulo

R3A 1M5

Winnipeg

N6A 5K8

London

G7H 5H6

Chicoutimi

H1T 1C8

Montreal

H2W 1R7

Montreal

G1V 4M6

Québec

J1H 5N4

Sherbrooke

WC1N 3BG

London

Sponsors
All Listed Sponsors
collaborator

Ionis Pharmaceuticals, Inc.

INDUSTRY

lead

Kastle Therapeutics, LLC

INDUSTRY