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Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care (AKKA)

This study has been terminated.
Information provided by (Responsible Party):
Karo Bio AB Identifier:
First received: July 13, 2011
Last updated: August 31, 2012
Last verified: August 2012

Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue.

The purpose of this Phase III study is to assess the long-term efficacy and safety of Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal standard of care.

Condition Intervention Phase
Heterozygous Familial Hypercholesterolaemia Drug: Placebo Drug: Eprotirome Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long Term Phase III Trial Assessing the Safety and Efficacy of Eprotirome in Patients With Heterozygous Familial Hypercholesterolaemia Who Are on Optimal Standard of Care

Resource links provided by NLM:

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:
  • Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline [ Time Frame: 12 weeks treatment ]

Enrollment: 236
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Tablets taken daily
Experimental: Eprotirome I Drug: Eprotirome
Tablets taken daily
Other Name: KB2115
Experimental: Eprotirome II Drug: Eprotirome
Tablets taken daily
Other Name: KB2115


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with confirmed HeFH and 18 years of age at screening
  • Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
  • Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
  • On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation

Exclusion Criteria:

  • Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01410383

Sponsors and Collaborators
Karo Bio AB
Principal Investigator: John Kastelein, Professor Academic Medical Center (AMC) of the University of Amsterdam
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karo Bio AB Identifier: NCT01410383     History of Changes
Other Study ID Numbers: KBT 009
Study First Received: July 13, 2011
Last Updated: August 31, 2012

Keywords provided by Karo Bio AB:
Heterozygous Familial Hypercholesterolaemia
coronary artery disease

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias processed this record on August 18, 2017