Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Biomarker/Laboratory analysis, Treatment | Active | 18 and over | Pharmaceutical / Industry | AP24534-12-301 NCT01650805 |
Summary
The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.
Further Study Information
This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib.
Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.
Eligibility Criteria
Inclusion Criteria:
1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) ≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate aminotransferase (AST) ≤2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
Trial Lead Organizations/Sponsors
ARIAD Pharmaceuticals, Incorporated
| Nikolaus S. Trede, MD, PhD | ![]() | Ph: (617) 494-0400 |
| Email: nikolaus.trede@ariad.com | ||
Trial Sites
| U.S.A. | |||
| California | |||
| Burbank | |||
| US Oncology - Providence Health System, Site #167 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Los Angeles | |||
| UCLA Department of Medicine, Site #027 | |||
| Pleasant Hill | |||
| Bay Area Cancer Research Group, Site #156 | |||
| Kaimiala Cardines | Ph: 925-676-3200 Ext.108 | ||
| Email: kcardines@bacrg.com | |||
| Bay Area Cancer Research Group, Site #157 | |||
| Kaimiala Cardines | Ph: 925-676-3200 Ext.108 | ||
| Email: kcardines@bacrg.com | |||
| Colorado | |||
| Boulder | |||
| Rocky Mountain Cancer Centers, Site #191 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Connecticut | |||
| Southington | |||
| Cancer Center of Central Connecticut, Site #147 | |||
| Mark Turney | Ph: 860-621-9316 | ||
| Email: mjt2716@sbcglobal.net | |||
| Delaware | |||
| Newark | |||
| Christiana Care Health Services, Site #155 | |||
| Kathy Combs | Ph: 302-623-4639 | ||
| Florida | |||
| Boynton Beach | |||
| University Cancer Institute, Site #149 | |||
| Arthur Voulgaris | Ph: 561-737-6556 Ext.116 | ||
| Email: tvoulgaris@universitycancerinstitute.com | |||
| Fort Meyers | |||
| Florida Cancer Specialists, Site #180 | |||
| Cara M. O'Keefe | Ph: 239-274-9930 | ||
| Email: cokeefe@flcancer.com | |||
| St. Petersburg | |||
| Florida Cancer Specialists, Site #179 | |||
| Christine Biermeier | Ph: 727-216-1143 | ||
| Email: cbiermeier@flcancer.com | |||
| Georgia | |||
| Atlanta | |||
| Emory University, Site #058 | |||
| Ann Shen | Ph: 404-778-1900 | ||
| Email: ann.shen@emory.edu | |||
| Illinois | |||
| Chicago | |||
| University of Chicago Cancer Research Center | |||
| Margaret Green, RN OCN | Ph: 773-702-0267 | ||
| Maywood | |||
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |||
| Kathy Kotula | Ph: 708-327-3317 | ||
| Email: kkotula@lumc.edu | |||
| Indiana | |||
| Indianapolis | |||
| Franciscan St. Francis Health, Site #138 | |||
| Elissa O'Malley, BSN | Ph: 317-528-7296 | ||
| Email: Elissa.Omalley@franciscanalliance.org | |||
| Iowa | |||
| Iowa City | |||
| Holden Comprehensive Cancer Center at University of Iowa | |||
| Karen Parrott | Ph: 319-353-6347 | ||
| Kansas | |||
| Wichita | |||
| US Oncology - Cancer Center of Kansas, Site #168 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Maryland | |||
| Baltimore | |||
| Greater Baltimore Medical Center, Site #140 | |||
| Dana Hack | Ph: 443-849-8139 | ||
| University of Maryland, Greenebaum Cancer Center, Site #040 | |||
| Veronica Fuller | Ph: 410-328-7332 | ||
| Email: vfuller@umm.edu | |||
| Massachusetts | |||
| Boston | |||
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |||
| Shannon Mililo | |||
| Email: Shannon_Milillo@dfci.harvard.edu | |||
| Massachusetts General Hospital | |||
| Regina Silver | Ph: 617-643-9866 | ||
| Email: rsilver@partners.org | |||
| Michigan | |||
| Ann Arbor | |||
| University of Michigan Medical Center, Site #011 | |||
| Emilija Mitrikeska | Ph: 734-647-8901 | ||
| Minnesota | |||
| Rochester | |||
| Mayo Clinic, Site #044 | |||
| Doug Waldner | |||
| Email: waldner.douglas@mayo.edu | |||
| Missouri | |||
| Kansas City | |||
| Saint Luke's Hospital, Site #162 | |||
| Julie Weiss | Ph: 816-932-1349 | ||
| Email: jaweiss@saint-lukes.org | |||
| Springfield | |||
| Mercy Medical Center | |||
| Adrianna Moore | |||
| Email: Adrianna.moore@mercy.net | |||
| Nebraska | |||
| Lincoln | |||
| Nebraska Hematology-Oncology, PC | |||
| Madhu Midathada, MD | Ph: 402-484-4908 | ||
| Email: mmidathada@yourcancercare.com | |||
| Nevada | |||
| Las Vegas | |||
| US Oncology - Comprehensive Cancer Center of Nevada, Site #169 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| New Jersey | |||
| Hackensack | |||
| John Theurer Cancer Center, Site #128 | |||
| Kevin Barga | |||
| Email: KBarga@hackensackUMC.org | |||
| New Mexico | |||
| Albuquerque | |||
| University of New Mexico Cancer Center, Site #166 | |||
| Kathy Anderson | Ph: 505-272-7813 | ||
| Email: kanderson@nmcca.org | |||
| New York | |||
| Mineola | |||
| Winthrop University Hospital, Site #153 | |||
| Michael Garrison | Ph: 516-663-9500 | ||
| New York | |||
| Memorial Sloan-Kettering Cancer Center | |||
| Ellin Berman | Ph: 212-639-7762 | ||
| Email: bermane@MSKCC.ORG | |||
| Weill Cornell Medical College, Site #006 | |||
| Tania J. Curcio | Ph: 212-746-2571 | ||
| Email: tjc9003@med.cornell.edu | |||
| Valhalla | |||
| New York Medical College, Site #146 | |||
| Paul Baskind | |||
| Email: Paul_Baskind@nymc.edu | |||
| Ohio | |||
| Middletown | |||
| Signal Point Clinical Research Center, Site #139 | |||
| Ben Agnew | |||
| Email: BAgnew@swohio.twcbc.com | |||
| Oklahoma | |||
| Oklahoma City | |||
| University of Oklahoma, Site #028 | |||
| Mohamad Cherry | Ph: 405-271-4022 | ||
| Email: Mohamad-cherry@ouhsc.edu | |||
| Bronwyn Bennett | Ph: 405-271-8777 | ||
| Email: Bronwyn-bennett@ouhsc.edu | |||
| Oregon | |||
| Portland | |||
| Oregon Health & Science University, Site #048 | |||
| Shara Reasor-Heard | Ph: 503-494-5074 | ||
| Email: reasorhe@ohsu.edu | |||
| Pennsylvania | |||
| Gettysburg | |||
| Gettysburg Cancer Center, Site #160 | |||
| Vansessa Hardman | |||
| Email: vhardman@gettysburgoncology.com | |||
| Pittsburgh | |||
| Western Pennsylvania Hospital, Site #159 | |||
| Lori Stover | Ph: 412-578-4392 | ||
| Email: lstover@wpahs.org | |||
| South Carolina | |||
| Charleston | |||
| Hollings Cancer Center at Medical University of South Carolina | |||
| Shanta Salzer | Ph: 843-792-1463 | ||
| Email: salzers@musc.edu | |||
| Luciano Costa | |||
| Email: costalj@musc.edu | |||
| Sumter | |||
| Carolina Hematology Oncology, Site #143 | |||
| Hanrry Paredes | Ph: 803-934-8348 | ||
| Email: hanrrypardes@hotmail.com | |||
| Tennessee | |||
| Nashville | |||
| Sarah Cannon Research Institute, Site #076 | |||
| Ask Sarah | Ph: 877-691-7274 | ||
| Texas | |||
| Austin | |||
| US Oncology - Texas Oncology Austin, Site #172 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Dallas | |||
| US Oncology - Texas Oncology Dallas, Site #171 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Midland | |||
| US Oncology - Texas Oncology Midland, Site #173 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| San Antonio | |||
| US Oncology - Cancer Care Center of South Texas, Site #170 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| Utah | |||
| Salt Lake City | |||
| Huntsman Cancer Institute, Site #043 | |||
| Debbie Herbert, CCRP | Ph: 801-213-4230 | ||
| Washington | |||
| Seattle | |||
| Seattle Cancer Care Alliance, Site #100 | |||
| Kaysey Orlowski | Ph: 800-804-8824 | ||
| Email: korlowsk@fhcrc.org | |||
| Vancouver | |||
| US Oncology - Northwest Cancer Specialists, Site #174 | |||
| Yolanda Caddick | |||
| Email: Yolanda.caddick@usoncology.com | |||
| West Virginia | |||
| Morgantown | |||
| West Virginia University, Site #154 | |||
| Angela Rishel | Ph: 304-293-2149 | ||
| Email: arishel@hsc.wvu.edu | |||
| Karen Stauffer | Ph: 304-581-1156 | ||
| Email: ksstauffer@hsc.wvu.edu | |||
| Australia | |||
| Perth | |||
| Royal Perth Hospital, Site #972 | |||
| Megan Margaria | Ph: +61 8 9224 7038 | ||
| Email: Megan.Margaria@health.wa.gov.au | |||
| Australian Capital Territory | |||
| Garran | |||
| Canberra Hospital, Site #971 | |||
| Anais Le Gall | Ph: +61 2 6244 4289 | ||
| Email: Anais.LeGall@act.gov.au | |||
| South Australia | |||
| Adelaide | |||
| Royal Adelaide Hospital, Site #951 | |||
| Lisa Carne | |||
| Email: lisa.carne@health.sa.gov.au | |||
| Victoria | |||
| East Melbourne | |||
| The Peter MacCallum Cancer Center, Site #950 | |||
| Carrie Donohoe | |||
| Email: Carrie.Donohoe@petermac.org | |||
| Melbourne | |||
| Box Hill Hospital, Site #940 | |||
| Lesley Poulton | |||
| Email: lesley.poulton@monash.edu | |||
| Belgium | |||
| Bruxelles | |||
| Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508 | |||
| Laurent Knoops | Ph: + 32 2 764 18 07 | ||
| Email: laurent.knoops@uclouvain.be | |||
| Leuven | |||
| UZ Gasthuisberg - Department of Hematology, Site #700 | |||
| Gregor Verhoef | Ph: 016/346880 | ||
| Email: gregor.verhoef@uzleuven.be | |||
| Canada | |||
| Ontario | |||
| Toronto | |||
| Princess Margaret Hospital | |||
| Lidia Casciaro | |||
| Email: Lidia.Casciaro@uhn.ca | |||
| Quebec | |||
| Montreal | |||
| Jewish General Hospital - Montreal | |||
| Penny Chipman | |||
| Email: penny.chipman@mcgill.ca | |||
| Czech Republic | |||
| Hradec Kralove | |||
| FN Hradec Kralove, Site #517 | |||
| Finland | |||
| Helsinki | |||
| Helsinki University Central Hospital, Site #542 | |||
| Kimmo Porkka | Ph: 358-947172338 | ||
| Email: kimmo.porkka@helsinki.fi | |||
| France | |||
| Bordeaux | |||
| Institut Bergonie, Site #772 | |||
| Le Chesnay Cedex | |||
| Centre Hospitalier de Versailles, Site #958 | |||
| Lille Cedex | |||
| Hospital Claude Huriez, Site #952 | |||
| Nancy Cedex | |||
| CHU de Brabois, Site #953 | |||
| Paris | |||
| Hospital Saint Antoine, Site #518 | |||
| Pierre Benite | |||
| Centre Hospitalier Lyon Sud, Site #956 | |||
| Poitiers | |||
| CHU de Poitiers, Site #954 | |||
| Germany | |||
| Aachen | |||
| Universitätsklinikum Aachen, AÖR, Site #513 | |||
| Tim H. Brümmendorf | Ph: 0049 241 8089805 | ||
| Email: tbruemmendorf@ukaachen.de | |||
| Berlin | |||
| Charite University Hospital - Campus Virchow Klinikum | |||
| Philipp le Coutre | Ph: 49 (0)30 450 553 077 | ||
| Email: philipp.lecoutre@charite.de | |||
| Dresden | |||
| Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526 | |||
| Rainer Ordemann | Ph: 0049 351-4588112 | ||
| Email: Rainer.Ordemann@uniklinikum-dresden.de | |||
| Freiburg | |||
| Universitatsklinikum Freiburg, Site #527 | |||
| Hamburg | |||
| Universitatsklinikum Hamburg-Eppendorf, Site #524 | |||
| Philippe Schafhausen | Ph: 0049 40-74105- 7122 | ||
| Email: schafhausen@uke.de | |||
| Jena | |||
| Klinikum der Friedrich-Schiller Universitaet Jena | |||
| Andreas Hochhaus | Ph: +49 (0)3641 932 4201 | ||
| Email: Andreas.Hochhaus@med.uni-jena.de | |||
| Koln | |||
| Universitatsklinikum Koln-AOR, Site #525 | |||
| Christof Scheid | Ph: 0049 221 478 98888 | ||
| Email: christoph.scheid@uk-koeln.de | |||
| Mannheim | |||
| Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947 | |||
| Regina Pleil-Losch | Ph: 49 (0) 621 383 6951 | ||
| Munchen | |||
| Klinikum rechts der Isar, Site #949 | |||
| Philipp J. Jost | Ph: 49 (089) 4140 5941 | ||
| Email: philipp.jost@lrz.tum.de | |||
| Hong Kong | |||
| Hong Kong | |||
| Queen Mary Hospital, Site #973 | |||
| Italy | |||
| Bari | |||
| Unita Operativa di Ematologia con Trapianto, Site #529 | |||
| Giorgina Specchia | Ph: 0039.080.5593471 | ||
| Email: g.specchia@ematba.uniba.it | |||
| Bologna | |||
| Istituto di Ematologia "L. & A. Seragnoli", Site #959 | |||
| Gianantonio Rosti | Ph: 0039 051 0516364076 | ||
| Email: totorosti@gmail.com | |||
| Catania | |||
| A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530 | |||
| Francesco Di Raimondo | Ph: 0039 0957435916 | ||
| Email: diraimon@unict.it | |||
| Genova | |||
| Clinica Ematologica, Site #528 | |||
| Marco Gobbi | Ph: 0103538953 | ||
| Email: marco.gobbi@unige.it | |||
| Milan | |||
| Ospedale Niguarda Ca'Granda | |||
| Ester Pungolino | Ph: 0039 02 6444 3965 | ||
| Email: ester.pungolino@ospedaleniguarda.it | |||
| Modena | |||
| S.C. Ematologia, Site #960 | |||
| Monza | |||
| San Gerardo Hospital, Site #961 | |||
| Carlo Gambacorti-Passerini | Ph: 0039 039 2339551 | ||
| Email: carlo.gambacorti@unimib.it | |||
| Napoli | |||
| Universita Federico II, Site #510 | |||
| Orbassano | |||
| SCDU Medicina Interna II - Indirizzo Ematologico, Site #785 | |||
| Netherlands | |||
| Amsterdam | |||
| Vrije Universiteit Medisch Centrum | |||
| New Zealand | |||
| Christchurch | |||
| Christchurch Hospital, Site #922 | |||
| Peter Ganly | |||
| Email: Peter.Ganly@cdhb.health.nz | |||
| Hamilton | |||
| Waikato Hospital, Site #977 | |||
| Humphrey Pullon | Ph: 64 7 839 8899 | ||
| Email: Humphrey.Pullon@waikatodhb.health.nz | |||
| Takapuna | |||
| North Shore Hospital, Site #976 | |||
| David Simpson | |||
| Email: David.Simpson@waitematadhb.govt.nz | |||
| Auckland | |||
| Grafton | |||
| Auckland City Hospital | |||
| Lucy Pemberton | |||
| Email: pemberl@adhb.govt.nz | |||
| Republic of Korea | |||
| Seocho-gu | |||
| The Catholic University of Korea, Site #938 | |||
| Prof. Dong-Wook Kim | Ph: 82-2-2258-7622 | ||
| Email: dwkim@catholic.ac.kr | |||
| Republic of Singapore | |||
| Singapore | |||
| Singapore General Hospital, Site #939 | |||
| Dr. Charles Chuah Thuan Heng | Ph: 65-63214855 | ||
| Email: Charles.chuah.t.h@sgh.com.sg | |||
| Slovakia | |||
| Bratislava | |||
| Narodny onkologicky ustav, Site #532 | |||
| Martin | |||
| Univerzitna nemocnica Martin, Site #533 | |||
| Spain | |||
| A Coruna | |||
| Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554 | |||
| Badalona | |||
| Hospital Universitari Germans Trias i Pujol, Site #512 | |||
| Barcelona | |||
| Hospital Clinic de Barcelona | |||
| Francisco Cervantes | Ph: 0034 93 227 54 28 | ||
| Email: FCERVAN@clinic.ub.es | |||
| Girona | |||
| Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734 | |||
| Islas Baleares | |||
| Hospital Universitari Son Espases, Site #553 | |||
| Madrid | |||
| H.U. Ramon y Cajal, Site #538 | |||
| Valentin Garcia | Ph: +34 913368686 | ||
| Email: jvalentingg@gmail.com | |||
| Hospital Gregorio Maranon, Site #536 | |||
| Santiago Osorio | Ph: 34628667388 | ||
| Email: sanosorio2000@yahoo.com | |||
| Hospital La Paz, Site #966 | |||
| Raquel de Paz | Ph: 0034 91 727 7116 | ||
| Email: depazraquel@gmail.com | |||
| Hospital Universitario 12 de Octubre, Site #537 | |||
| Joaquín Martínez | Ph: 34917792787 | ||
| Email: jmartinezlo@hematologia12octubre.com | |||
| Oviedo | |||
| Hospital Universitario Central de Asturias, Site #535 | |||
| Angel Ramirez | |||
| Email: apayer.angel@gmail.com | |||
| Salamanca | |||
| University Hospital - Salamanca | |||
| Fermin Sanchez Guijo | Ph: +34923291384 | ||
| Email: ferminsg@usal.es | |||
| Valencia | |||
| Hospital Clinico Universitario de Valencia, Site #964 | |||
| Juan Carlos Hernandez Boluda | Ph: 0034 963987832 | ||
| Email: hernandez_jca@gva.es | |||
| Sweden | |||
| Lund | |||
| Lund University Hospital | |||
| Maria Hector | Ph: 004646 17 7141 | ||
| Email: maria.hector@skane.se | |||
| Stockholm | |||
| Karolinska University Hospital - Solna | |||
| Karolinska University Hospital Huddinge, Site #534 | |||
| Uppsala | |||
| Uppsala University Hospital, Site #945 | |||
| Ulla Olsson-Stromberg | Ph: 46186110000 | ||
| Email: ulla.stromberg@talk21.com | |||
| Switzerland | |||
| Aarau | |||
| Kantonsspital Aarau, Site #541 | |||
| Mario Bargetzi | Ph: 0041 62 838 60 53 | ||
| Email: mario.bargetzi@ksa.ch | |||
| Taiwan | |||
| Taiching | |||
| China Medical University Hospital, Site #978 | |||
| Su-Peng Yeh | |||
| Contact Person | Ph: 886-4-22052121 Ext.5051 | ||
| Email: supengyeh@gmail.com | |||
| Taipei | |||
| National Taiwan University Hospital, Site #979 | |||
| United Kingdom | |||
| Glasgow | |||
| University of Glasgow, Site #797 | |||
| Leeds | |||
| St. James University Hospital, Site #540 | |||
| Liverpool | |||
| Royal Liverpool University Hospital, Site #969 | |||
| Richard Clark | Ph: 44 151 706 4297 | ||
| Email: R.E.Clark@liverpool.ac.uk | |||
| London | |||
| Hammersmith Hospital, Site #967 | |||
| Jane Apperley | Ph: +44 20 8383 4017 | ||
| Email: j.apperley@imperial.ac.uk | |||
| Newcastle | |||
| Newcastle University, Site #970 | |||
| Stephen O'Brien | Ph: +44 191 282 0904 | ||
| Email: s.g.o'brien@ncl.ac.uk | |||
| Nottingham | |||
| Nottingham University Hospitals NHS Trust, Site #968 | |||
| Jennifer Byrne | Ph: +44 115 962 7708 | ||
| Email: jenny.byrne@nottingham.ac.uk | |||
| Oxford | |||
| Oxford University Hospitals NHS Trust, Site #543 | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01650805
Information obtained from ClinicalTrials.gov on May 09, 2013
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