Clinical trial NCT02102204: Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Official title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Detailed description: This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Eligibility criteria: Inclusion Criteria:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures
* Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
* Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
* Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
* Subject has known sensitivity to any of the products or components to be administered during dosing
* Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
* Subject is receiving dialysis prescription dialysate calcium concentration \< 2.25 mEq/L
* Subject is pregnant or nursing

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.
Secondary outcomes:
measure: Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
timeFrame: Months 6, 12, and 18
measure: Percentage of Participants With Serum Phosphorus ≤ the ULN
timeFrame: Months 6, 12, and 18
measure: Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
timeFrame: From day 1 to months 6, 12, and 18
measure: Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
timeFrame: Baseline to end of treatment; median duration of treatment was 563 days.
measure: Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
timeFrame: Baseline and every 6 months (up to 24 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Alhambra
country: United States
facility: Research Site
state: California
city: Azusa
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Cudahy
country: United States
facility: Research Site
state: California
city: Granada Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Simi Valley
country: United States
facility: Research Site
state: California
city: Vacaville
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Westminster
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Augusta
country: United States
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state: Georgia
city: Dublin
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state: Georgia
city: Meridian
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state: Idaho
city: Highland Park
country: United States
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state: Illinois
city: Merrillville
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state: Indiana
city: Michigan City
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state: Indiana
city: Wichita
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state: Kansas
city: Baton Rouge
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state: Louisiana
city: Springfield
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state: Massachusetts
city: Detroit
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city: Pontiac
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city: Brookhaven
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city: Columbus
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city: Tupelo
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city: Lincoln
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city: Las Vegas
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city: Reno
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state: New Jersey
city: Voorhees
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city: Brooklyn
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city: College Point
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city: Great Neck
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city: Mineola
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city: Rosedale
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state: New York
city: The Bronx
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city: Yonkers
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state: New York
city: Durham
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state: North Carolina
city: New Bern
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state: North Carolina
city: Wilmington
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state: North Carolina
city: Cincinnati
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city: Columbus
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city: Oklahoma City
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city: Bethlehem
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state: Pennsylvania
city: Philadelphia
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city: Columbia
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city: Chattanooga
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state: Tennessee
city: Knoxville
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city: Arlington
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city: Edinburg
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city: Houston
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city: Fairfax
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city: Hampton
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city: Mechanicsville
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state: West Virginia
city: Liverpool
country: Australia
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state: New South Wales
city: Westmead
country: Australia
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state: New South Wales
city: Brisbane
country: Australia
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state: Queensland
city: Adelaide
country: Australia
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state: South Australia
city: Clayton
country: Australia
facility: Research Site
state: Victoria
city: Prahan
country: Australia
facility: Research Site
state: Victoria
city: Feldkirch
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Wien
country: Austria
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city: Wien
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Baudour
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
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city: Hasselt
country: Belgium
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city: Kortrijk
country: Belgium
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city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
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city: Liège
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
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city: Tournai
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Saint John
country: Canada
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state: New Brunswick
city: St. Johns
country: Canada
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state: Newfoundland and Labrador
city: Brampton
country: Canada
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state: Ontario
city: Greenfield Park
country: Canada
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state: Quebec
city: Montreal
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city: Hradec Kralove
country: Czechia
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city: Novy Jicin
country: Czechia
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city: Plzen
country: Czechia
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city: Praha 4 - Nusle
country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Denmark
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country: Denmark
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country: France
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city: La Tronche cedex
country: France
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country: France
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country: France
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city: Paris
country: France
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country: France
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country: France
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country: France
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Minden
country: Germany
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city: München
country: Germany
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city: Villingen-Schwenningen
country: Germany
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city: Wiesbaden
country: Germany
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city: Zwickau
country: Germany
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city: Alexandroupoli
country: Greece
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city: Larissa
country: Greece
facility: Research Site
city: Nikaia, Piraeus
country: Greece
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city: Patra
country: Greece
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city: Thessaloniki
country: Greece
facility: Research Site
city: Baja
country: Hungary
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city: Budapest
country: Hungary
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city: Esztergom
country: Hungary
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city: Gyor
country: Hungary
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city: Kaposvar
country: Hungary
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city: Kistarcsa
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
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city: Szigetvar
country: Hungary
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city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Firenze
country: Italy
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city: Genova
country: Italy
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city: Lecco
country: Italy
facility: Research Site
city: Lucca
country: Italy
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city: Milano
country: Italy
facility: Research Site
city: Pavia
country: Italy
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city: Pisa
country: Italy
facility: Research Site
city: Pordenone
country: Italy
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city: Verona
country: Italy
facility: Research Site
city: Riga
country: Latvia
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city: Alytus
country: Lithuania
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city: Kaunas
country: Lithuania
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country: Lithuania
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city: Ukmerge
country: Lithuania
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city: Rotterdam
country: Netherlands
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city: Venlo
country: Netherlands
facility: Research Site
city: Hamilton
country: New Zealand
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city: Gdansk
country: Poland
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city: Golub-Dobrzyn
country: Poland
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city: Katowice
country: Poland
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country: Poland
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city: Lodz
country: Poland
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city: Poznan
country: Poland
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city: Poznan
country: Poland
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city: Sieradz
country: Poland
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city: Wadowice
country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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city: Zyrardow
country: Poland
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city: Almada
country: Portugal
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city: Aveiro
country: Portugal
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city: Forte da Casa
country: Portugal
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city: Guimarães
country: Portugal
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city: Lisboa
country: Portugal
facility: Research Site
city: Santo Tirso
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Vila Franca de Xira
country: Portugal
facility: Research Site
city: Mitishi
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Lleida
country: Spain
facility: Research Site
state: Cataluña
city: Torrevieja
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: Research Site
state: Extremadura
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Locarno
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: