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Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

NCT ID: NCT02102204

Last Updated: 2017-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-25

Study Completion Date

2017-06-26

Brief Summary

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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

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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.

Conditions

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Hyperparathyroidism, Secondary

Keywords

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Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etelcalcetide

Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.

Group Type EXPERIMENTAL

Etelcalcetide

Intervention Type DRUG

Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Interventions

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Etelcalcetide

Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Intervention Type DRUG

Other Intervention Names

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KAI-4169 AMG 416 Parasabiv

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Birmingham, Alabama, United States

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Alhambra, California, United States

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Azusa, California, United States

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Bakersfield, California, United States

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Cudahy, California, United States

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Granada Hills, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Riverside, California, United States

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Simi Valley, California, United States

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Vacaville, California, United States

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Whittier, California, United States

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Aurora, Colorado, United States

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Westminster, Colorado, United States

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Stamford, Connecticut, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Dublin, Georgia, United States

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Meridian, Idaho, United States

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Highland Park, Illinois, United States

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Merrillville, Indiana, United States

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Michigan City, Indiana, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Pontiac, Michigan, United States

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Brookhaven, Mississippi, United States

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Columbus, Mississippi, United States

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Gulfport, Mississippi, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Eatontown, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Brooklyn, New York, United States

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College Point, New York, United States

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Great Neck, New York, United States

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Mineola, New York, United States

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Rosedale, New York, United States

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The Bronx, New York, United States

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Yonkers, New York, United States

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Durham, North Carolina, United States

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New Bern, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Fairfax, Virginia, United States

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Hampton, Virginia, United States

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Mechanicsville, Virginia, United States

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Bluefield, West Virginia, United States

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Liverpool, New South Wales, Australia

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Westmead, New South Wales, Australia

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Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

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Prahan, Victoria, Australia

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Feldkirch, , Austria

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Graz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Baudour, , Belgium

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Bonheiden, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Hasselt, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Roeselare, , Belgium

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Tournai, , Belgium

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Edmonton, Alberta, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Hradec Králové, , Czechia

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Nový Jičín, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Praha 4 - Nusle, , Czechia

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Slavkov u Brna, , Czechia

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Ústí nad Orlicí, , Czechia

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Copenhagen, , Denmark

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Fredericia, , Denmark

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Caen, , France

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La Tronche, , France

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Lille, , France

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Marseille, , France

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Paris, , France

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Paris, , France

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Reims, , France

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Saint-Ouen, , France

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Saint-Priest-en-Jarez, , France

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Aachen, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Langenhagen, , Germany

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Minden, , Germany

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München, , Germany

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Villingen-Schwenningen, , Germany

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Wiesbaden, , Germany

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Zwickau, , Germany

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Alexandroupoli, , Greece

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Larissa, , Greece

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Nikaia, Piraeus, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Baja, , Hungary

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Budapest, , Hungary

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Esztergom, , Hungary

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Győr, , Hungary

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Kaposvár, , Hungary

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Kistarcsa, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Pécs, , Hungary

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Székesfehérvár, , Hungary

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Szigetvár, , Hungary

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Zalaegerszeg, , Hungary

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Ashkelon, , Israel

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Jerusalem, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Ẕerifin, , Israel

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Ancona, , Italy

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Florence, , Italy

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Genova, , Italy

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Lecco, , Italy

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Lucca, , Italy

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Milan, , Italy

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Pavia, , Italy

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Pisa, , Italy

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Pordenone, , Italy

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Verona, , Italy

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Riga, , Latvia

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Alytus, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Ukmerge, , Lithuania

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Rotterdam, , Netherlands

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Venlo, , Netherlands

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Hamilton, , New Zealand

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Gdansk, , Poland

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Golub-Dobrzyń, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Sieradz, , Poland

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Wadowice, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Zamość, , Poland

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Żyrardów, , Poland

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Almada, , Portugal

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Aveiro, , Portugal

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Forte Da Casa, , Portugal

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Guimarães, , Portugal

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Lisbon, , Portugal

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Santo Tirso, , Portugal

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Setúbal, , Portugal

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Vila Franca de Xira, , Portugal

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Mitishi, , Russia

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Moscow, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Córdoba, Andalusia, Spain

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Santander, Cantabria, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Lleida, Catalonia, Spain

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Badajoz, Extremadura, Spain

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Majadahonda, Madrid, Spain

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Pamplona, Navarre, Spain

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Torrevieja, Valencia, Spain

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Valencia, Valencia, Spain

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Madrid, , Spain

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Madrid, , Spain

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Karlstad, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Trollhättan, , Sweden

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Uppsala, , Sweden

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Aarau, , Switzerland

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Bern, , Switzerland

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Lausanne, , Switzerland

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Locarno, , Switzerland

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Zurich, , Switzerland

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Australia Austria Belgium Canada Czechia Denmark France Germany Greece Hungary Israel Italy Latvia Lithuania Netherlands New Zealand Poland Portugal Russia Spain Sweden Switzerland Turkey (Türkiye)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2013-004136-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KAI-4169

Identifier Type: OTHER

Identifier Source: secondary_id

20130213

Identifier Type: -

Identifier Source: org_study_id