- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694197
Long Term Safety Study of PRALUENT
Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).
The secondary objectives of the study were:
- To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
- To evaluate the effect of PRALUENT on other lipid parameters
- To evaluate the effect of PRALUENT on gonadal steroid hormones
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pleven, Bulgaria, 5800
- Regeneron Research Site
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Plovdiv, Bulgaria, 4000
- Regeneron Research Site
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Sofia, Bulgaria, 1309
- Regeneron Research Site
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Sofia, Bulgaria, 1407
- Regeneron Research Site
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Sofia, Bulgaria, 1784
- Regeneron Research Site #2
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Stara Zagora, Bulgaria, 6000
- Regeneron Research Site
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Varna, Bulgaria, 9000
- Regeneron Research Site
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Paide, Estonia, 72713
- Regeneron Research Site
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Tallinn, Estonia, 10128
- Regeneron Research Site #2
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Tallinn, Estonia, 10617
- Regeneron Research Site
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Tartu, Estonia, 51014
- Regeneron Research Site
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Harjumaa
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Tallinn, Harjumaa, Estonia, 10138
- Regeneron Research Site
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Ekaterinburg, Russian Federation, 620109
- Regeneron Research Site
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Ivanovo, Russian Federation, 153012
- Regeneron Research Site
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Kirov, Russian Federation, 610014
- Regeneron Research Site
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Moscow, Russian Federation, 121309
- Regeneron Research Site
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Moscow, Russian Federation, 121359
- Regeneron Research Site
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Moscow, Russian Federation, 121552
- Regeneron Research Site
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Novosibirsk, Russian Federation, 630008
- Regeneron Research Site
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Rostov-na-Donu, Russian Federation, 344068
- Regeneron Research Site
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Saint Petersburg, Russian Federation, 197376
- Regeneron Research Site
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Saint-Petersburg, Russian Federation, 193312
- Regeneron Research Site
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Saint-Petersburg, Russian Federation, 198205
- Regeneron Research Site
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Saratov, Russian Federation, 410028
- Regeneron Research Site
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St. Petersburg, Russian Federation, 192288
- Regeneron Research Site #2
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St. Petersburg, Russian Federation, 192288
- Regeneron Research Site
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St. Petersburg, Russian Federation, 195112
- Regeneron Research Site
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St. Petersburg, Russian Federation, 197376
- Regeneron Research Site
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St. Petersburg, Russian Federation, 197706
- Regeneron Research Site
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Sverdlovskaya, Russian Federation, 620109
- Regeneron Research Site
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Tyumen, Russian Federation, 625032
- Regeneron Research Site
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Yaroslavl, Russian Federation, 150030
- Regeneron Research Site 1
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Yaroslavl, Russian Federation, 150030
- Regeneron Research Site 2
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Bloemfontein, South Africa, 9301
- Regeneron Research Site
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Claremont, South Africa, 7708
- Regeneron Research Site
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Johannesburg, South Africa, 2013
- Regeneron Research Site
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Cape Town
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Kuilsrivier, Cape Town, South Africa, 7580
- Regeneron Research Site
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Parow, Cape Town, South Africa, 7500
- Regeneron Research Site
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Eastern Cape
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Port Elizabeth, Eastern Cape, South Africa, 6001
- Regeneron Research Site
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Gauteng
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Halfway House, Gauteng, South Africa, 1685
- Regeneron Research Site
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Pretoria, Gauteng, South Africa, 0002
- Regeneron Research Site
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Pretoria, Gauteng, South Africa, 0122
- Regeneron Research Site
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Pretoria, Gauteng, South Africa, 0184
- Regeneron Research Site
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Pretoria West, Gauteng, South Africa, 183
- Regeneron Research Site
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Johannesburg
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Kempton Park, Johannesburg, South Africa, 1619
- Regeneron Research Site
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Soweto, Johannesburg, South Africa, 1818
- Regeneron Research Site
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Western Cape
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Cape Town, Western Cape, South Africa, 7530
- Regeneron Research Site
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Cape Town, Western Cape, South Africa, 7925
- Regeneron Research Site
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George, Western Cape, South Africa, 6529
- Regeneron Research Site
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Paarl, Western Cape, South Africa, 7646
- Regeneron Research Site
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Somerset West, Western Cape, South Africa, 7130
- Regeneron Research Site
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Worcester, Western Cape, South Africa, 6850
- Regeneron Research Site
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Kharkiv, Ukraine, 61002
- Regeneron Research Site #2
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Kharkov, Ukraine, 61039
- Regeneron Research Site
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Kiev, Ukraine, 2091
- Regeneron Research Site
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Kyiv, Ukraine, 02002
- Regeneron Research Site
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Kyiv, Ukraine, 02660
- Regeneron Research Site
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Kyiv, Ukraine, 03037
- Regeneron Research Site
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Kyiv, Ukraine, 03049
- Regeneron Research Site
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Kyiv, Ukraine, 03115
- Regeneron Research Site
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Kyiv, Ukraine, 04114
- Regeneron Research Site #2
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Kyiv, Ukraine
- Regeneron Research Site
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Lviv, Ukraine, 79015
- Regeneron Research Site
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Uzhorod, Ukraine, 88000
- Regeneron Research Site
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Vinnitsa, Ukraine, 21029
- Regeneron Research Site
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Vinnitsya, Ukraine, 21018
- Regeneron Research Site
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Vinnytsya, Ukraine, 21018
- Regeneron Research Site
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Alabama
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Auburn, Alabama, United States, 36830
- Regeneron Research Site
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Mobile, Alabama, United States, 36608
- Regeneron Research Site
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California
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Beverly Hills, California, United States, 90210
- Regeneron Research Site
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Los Gatos, California, United States, 95032
- Regeneron Research Site
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North Hollywood, California, United States, 91606
- Regeneron Research Site
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Port Hueneme, California, United States, 93041
- Regeneron Research Site
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Colorado
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Aurora, Colorado, United States, 80012
- Regeneron Research Site
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Colorado Springs, Colorado, United States, 80906
- Regeneron Research Site
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Florida
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Lake Worth, Florida, United States, 33461
- Regeneron Research Site
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Miami Springs, Florida, United States, 33166
- Regeneron Research Site
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Illinois
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Champaign, Illinois, United States, 61822
- Regeneron Research Site
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Indiana
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Evansville, Indiana, United States, 47714
- Regeneron Research Site
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Indianapolis, Indiana, United States, 46237
- Regeneron Research Site
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Iowa
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Ames, Iowa, United States, 50010-30144
- Regeneron Research Site
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Iowa City, Iowa, United States, 52242
- Regeneron Research Site
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Waterloo, Iowa, United States, 50702
- Regeneron Research Site
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Kansas
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Newton, Kansas, United States, 67114
- Regeneron Research Site
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Kentucky
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Louisville, Kentucky, United States, 40213
- Regeneron Research Site
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Maine
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Bangor, Maine, United States, 04401
- Regeneron Research Site
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Maryland
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Baltimore, Maryland, United States, 21229
- Regeneron Research Site
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Oxon Hill, Maryland, United States, 20745
- Regeneron Research Site
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Mississippi
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Olive Branch, Mississippi, United States, 38654
- Regeneron Research Site
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Missouri
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Washington, Missouri, United States, 63090
- Regeneron Research Site
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New York
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Buffalo, New York, United States, 14215
- Regeneron Research Site
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New Hyde Park, New York, United States, 11042
- Regeneron Research Site
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North Carolina
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Cary, North Carolina, United States, 27518
- Regeneron Research Site
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Charlotte, North Carolina, United States, 28209
- Regeneron Research Site
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Charlotte, North Carolina, United States, 28277
- Regeneron Research Site
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Greensboro, North Carolina, United States, 27401
- Regeneron Research Site
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Hickory, North Carolina, United States, 28601
- Regeneron Research Site
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Raleigh, North Carolina, United States, 27609
- Regeneron Research Site
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Rocky Mount, North Carolina, United States, 27804
- Regeneron Research Site
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Salisbury, North Carolina, United States, 28144
- Regeneron Research Site
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Statesville, North Carolina, United States, 28625
- Regeneron Research Site
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Wilmington, North Carolina, United States, 28401
- Regeneron Research Site
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Winston-Salem, North Carolina, United States, 27103
- Regeneron Research Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Regeneron Research Site
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Cleveland, Ohio, United States, 44122
- Regeneron Research Site
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Dayton, Ohio, United States, 45414
- Regeneron Research Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- Regeneron Research Site
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Summerville, South Carolina, United States, 29485
- Regeneron Research Site
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Regeneron Research Site
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Tennessee
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Bristol, Tennessee, United States, 37620
- Regeneron Research Site
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Knoxville, Tennessee, United States, 37760
- Regeneron Research Site 2
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Knoxville, Tennessee, United States, 37912
- Regeneron Research Site 3
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Knoxville, Tennessee, United States, 37938
- Regeneron Research Site
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Powell, Tennessee, United States, 37849
- Regeneron Research Site
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Texas
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Dallas, Texas, United States, 75231
- Regeneron Research Site
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Houston, Texas, United States, 77027
- Regeneron Research Site
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Schertz, Texas, United States, 78154
- Regeneron Research Site
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Shavano Park, Texas, United States, 78213
- Regeneron Research Site
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Shavano Park, Texas, United States, 78231
- Regeneron Research Site
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Virginia
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Falls Church, Virginia, United States, 22042
- Regeneron Research Site
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Winchester, Virginia, United States, 22601
- Regeneron Research Site
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Washington
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Tacoma, Washington, United States, 98405
- Regeneron Research Site
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Walla Walla, Washington, United States, 99362
- Regeneron Research Site
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Wisconsin
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Manitowoc, Wisconsin, United States, 54220
- Regeneron Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.
Key Exclusion Criteria:
- Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
- Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
- Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
- Known hypersensitivity to monoclonal antibody or any component of the drug product
- Pregnant or breastfeeding women
Note: Other inclusion/ exclusion criteria apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open label
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Subcutaneous (SC) administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
Time Frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
|
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug.
AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI).
AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
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After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
Time Frame: Up to week 72
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The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
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Up to week 72
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Percent Change in LDL-C From Baseline Over Time
Time Frame: Up to week 72
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Up to week 72
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Total Cholesterol (Total-C) Values From Baseline Over Time
Time Frame: Up to week 72
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The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Percent Change From Baseline in Total-C Over Time
Time Frame: Up to week 72
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Up to week 72
|
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Lipoprotein a (Lp(a)) Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
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Percent Change From Baseline in Lp(a) Over Time
Time Frame: Up to week 72
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Up to week 72
|
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Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
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Percent Change From Baseline in Non-HDL-C Over Time
Time Frame: Up to week 72
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Up to week 72
|
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High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Percent Change From Baseline in HDL-C Over Time
Time Frame: Up to week 72
|
Up to week 72
|
|
Fasting Triglycerides (TGs) Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
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Percent Change From Baseline in Fasting TGs Over Time
Time Frame: Up to week 72
|
Up to week 72
|
|
Apolipoprotein B (Apo B) Values From Baseline Over Time
Time Frame: Up to week 72
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The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
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Percent Change From Baseline in Apo B Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
Time Frame: Up to week 72
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The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
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Percent Change From Baseline in Apo A1 Over Time
Time Frame: Up to week 72
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Up to week 72
|
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Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Alanine Aminotransferase Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Alanine Aminotransferase Over Time
Time Frame: Up to week 72
|
Up to week 72
|
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Aspartate Aminotransferase Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Aspartate Aminotransferase Over Time
Time Frame: Up to week 72
|
Up to week 72
|
|
Alkaline Phosphatase Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Alkaline Phosphatase Over Time
Time Frame: Up to week 72
|
Up to week 72
|
|
Total Bilirubin Values From Baseline Over Time
Time Frame: Up to week 72
|
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
|
Up to week 72
|
Change From Baseline in Total Bilirubin Over Time
Time Frame: Up to week 72
|
Up to week 72
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R727-CL-1609
- 2018-002810-11 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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