Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders (TAUSSIG)
This study is currently recruiting participants.
Verified June 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01624142
First received: June 5, 2012
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
A study to assess the long term safety and efficacy of AMG 145 on Low Density Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Homozygous Familial Hypercholesterolemia or PCSK9 Mutations |
Drug: AMG 145 |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Subject incidence of treatment emergent adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Subject incidence of treatment emergent adverse events
Secondary Outcome Measures:
- Percent change in low density lipoprotein-cholesterol [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]Percent change in low density lipoprotein-cholesterol from baseline open label at each scheduled visit
- Percent change in non-high density lipoprotein-cholesterol [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]Percent change in non-high density lipoprotein- cholesterol from baseline open label at each scheduled visit
- Percent change in apolipoprotein B [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]Percent change in apolipoprotein B from baseline open label at each scheduled visit
- Percent change in total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]Percent change in total cholesterol/high density lipoprotein-cholesterol ratio from baseline open label at each scheduled visit
- Percent change in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: Every scheduled visit over 5 years ] [ Designated as safety issue: No ]Percent change in apolipoprotein B/apolipoprotein A1 ratio from baseline open label at each scheduled visit
| Estimated Enrollment: | 125 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | November 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dose 1 of subcutaneous AMG 145
Dose 1 of subcutaneous AMG 145 every month
|
Drug: AMG 145
every month
|
|
Experimental: Dose 2 of subcutaneous AMG 145
Dose 2 of subcutaneous AMG 145 every 2 weeks
|
Drug: AMG 145
every 2 weeks
|
Eligibility| Ages Eligible for Study: | 12 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completed Study 20110233 or another qualifying protocol OR
- Have severe familial hypercholesterolemia due to genetic causes beyond LDL receptor mutations OR
- Have homozygous familial hypercholesterolemia OR
- eligible for study 20110233 as diagnosed with homozygous familiar hypercholesterolemia but study 20110233 already closed.
- Males and females ≥ 12 to ≤ 65 years of age
- Stable low-fat diet and lipid-lowering therapies for at least 4 weeks
- Low Density Lipoprotein - Cholesterol (LDL-C) >=130 mg/dl (3.4 mmol/L) for subjects without diagnosed CDH/CHD risk equivalent OR LDL-C >= 100 mg/dl (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent OR apheresis patients have no LDL-C entry requirement
- Fasting triglycerides < 400 mg/dL(4.5 mmol/L)
- Bodyweight of > 40 kg or greater at screening
Exclusion Criteria:
- New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of screening
- Planned cardiac surgery or revascularization
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624142
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| United States, Ohio | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45227 | |
| Contact: Research Site | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45227 | |
| Australia, Western Australia | |
| Research Site | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Research Site | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Canada, Quebec | |
| Research Site | Recruiting |
| Chicoutimi, Quebec, Canada, G7H 7K9 | |
| Canada | |
| Research Site | Recruiting |
| Quebec, Canada, G1V 4G2 | |
| Czech Republic | |
| Research Site | Recruiting |
| Brno, Czech Republic, 656 91 | |
| Research Site | Recruiting |
| Hradec Kralove, Czech Republic, 500 05 | |
| Greece | |
| Research Site | Recruiting |
| Athens, Greece, 17674 | |
| Japan | |
| Research Site | Recruiting |
| Kanazawa, Ishikawa, Japan, 920-8641 | |
| Research Site | Recruiting |
| Suita, Osaka, Japan, 565-8565 | |
| New Zealand | |
| Research Site | Recruiting |
| Christchurch, New Zealand, 8011 | |
| South Africa | |
| Research Site | Recruiting |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Research Site | Recruiting |
| Observatory, Western Cape, South Africa, 7925 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01624142 History of Changes |
| Other Study ID Numbers: | 20110271 |
| Study First Received: | June 5, 2012 |
| Last Updated: | June 12, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada South Africa: Medicines Control Council Greece: National Organization of Medicines New Zealand: Medsafe Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Directorate-General for Medicinal Products Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Amgen:
|
Hypercholesterolemia Elevated Cholesterol High Cholesterol Homozygous Familial Hypercholesterolemia PCSK9 mutations |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
ClinicalTrials.gov processed this record on June 18, 2013