A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
Study Details
Study Description
Brief Summary
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir.
Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it.
After treatment, each participant will be followed up for up to 12 weeks.
Participants will visit their study clinic up to 18 times during the study.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Maribavir/ Placebo Participants will receive 400 milligrams (mg) of maribavir (2*200 mg tablets) twice daily (BID) orally along with a placebo matched to valganciclovir for 8 weeks. |
Drug: Maribavir
Participants will receive 400 mg of maribavir BID orally.
Other: Placebo
Participants will receive placebo tablets matched to either maribavir or valganciclovir.
|
Active Comparator: Valganciclovir/ Placebo Participants will receive 900 mg of valganciclovir (2*450 mg tablets) BID orally along with a placebo matched to maribavir for 8 weeks. Valganciclovir dose may be adjusted to 450 mg BID or 450 mg QD during the study for renal function impairment or neutropenia. |
Drug: Valganciclovir
Participants will receive valganciclovir tablets orally.
Other: Placebo
Participants will receive placebo tablets matched to either maribavir or valganciclovir.
|
Outcome Measures
Primary Outcome Measures
- Proportion of Participants With Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at the End of Study Week 8, Regardless of Whether Study Assigned Treatment was Completed [Week 8]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. The participant must have received exclusively study-assigned treatment.
Secondary Outcome Measures
- Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance Achieved at the End of Study Week 8 Through Study Week 16, Regardless of Whether Study Assigned Treatment was Completed [Week 8 through Week 16]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay. The participant must have received exclusively study-assigned treatment and must also have symptom control.
- Proportion of Participants Who Achieve Confirmed CMV Viremia Clearance After 8 Weeks of Receiving Study-assigned Treatment [Week 8]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay.
- Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12, 16 and 20 [Week 8 through Weeks 12, 16 and 20]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay.
- Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment was Completed [Week 8 through Weeks 12 and 20]
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay. The participant must have received exclusively study-assigned treatment and also must have symptom control.
- Proportion of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment [Baseline up to Week 20]
Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the followup study phase, and at any time during the study.
- Incidence of Grade 3 or 4 Neutropenia [Baseline up to Week 8]
Grade 3 and grade 4 neutropenia are defined as absolute neutophil count (ANC) <1000 per cubic millimeter (/mm^3) and ANC <500/mm^3 respectively.
- Number of Participants With Treatment-Emergent Adverse Events [Baseline up to Week 20]
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE).
- Predose Concentration (Cmin) of Maribavir [Weeks 1, 4, and 8: pre-morning dose]
- Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only [Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
- Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only [Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
- Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only [Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
- Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only [Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
- Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only [Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).
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Be greater than or equal to (>=) 16 years of age at the time of consent.
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Be a recipient of hematopoietic stem cell transplant.
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Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=1365 International Units per millilitre (IU/mL) to less than or equal to (<=) 273000 IU/mL in whole blood or >=455 IU/mL to <=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (<) 910 and >=455 IU/mL in plasma or <2730 and >=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible:
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Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR,
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Haploidentical donor
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Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,
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Use of umbilical cord blood as stem cell source,
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Use of ex vivo T-cell-depleted grafts,
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Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of systemic corticosteroids (defined as the use of >=1 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).
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Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
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Per investigator's judgment, be eligible for treatment with valganciclovir.
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Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
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Absolute neutrophil count to >=1000 per cubic millimeter (/mm3) [1.0*109/L].
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Platelet count >=25,000/mm3 [25*109/L].
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Hemoglobin >=8 grams per deciliter (g/dL).
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Estimated creatinine clearance >=30 milliliters per minute (mL/min).
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Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.
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Be able to swallow tablets.
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Have life expectancy of >=8 weeks.
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Weigh >=40 kilograms (kg).
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Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
Exclusion Criteria:
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Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
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Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
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Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a participants who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes during active surveillance, based on same local laboratory and same sample type). The Participants must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
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Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.
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Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated.
Note: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
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Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.
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Have known hypersensitivity to the active substance or to an excipient of the study treatments.
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Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
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Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
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Be female and pregnant or nursing.
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Have previously completed, discontinued, or have been withdrawn from this study.
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Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.
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Have received any unapproved agent or device within 30 days before initiation of study treatment.
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Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
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Have previously received maribavir.
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Have serum aspartate aminotransferase (AST) greater than (>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) >5 times ULN at screening, or total bilirubin >= 3.0*ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central laboratory.
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Have known (previously documented) positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
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Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled.
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Be undergoing treatment for acute or chronic hepatitis C
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
2 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
3 | Stanford University | Stanford | California | United States | 94305 |
4 | Colorado Blood Cancer Institute - PPDS | Denver | Colorado | United States | 80218 |
5 | Yale University School of Medicine | New Haven | Connecticut | United States | 06520 |
6 | Emory University | Atlanta | Georgia | United States | 30322 |
7 | University of Chicago | Chicago | Illinois | United States | 60637 |
8 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
9 | University of Maryland School of Medicine | Baltimore | Maryland | United States | 21201 |
10 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21205 |
11 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
12 | Brigham and Womens Hospital | Boston | Massachusetts | United States | 02115 |
13 | UMass Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
14 | Harper University Hospital | Detroit | Michigan | United States | 48201 |
15 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
16 | University of Minnesota | Minneapolis | Minnesota | United States | 55454 |
17 | Mayo Clinic - PIN | Rochester | Minnesota | United States | 59905 |
18 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
19 | Joan and sandford I. Weill Medical College of Cornell University Clinic | New York | New York | United States | 10021 |
20 | Columbia University Medical Center | New York | New York | United States | 10032 |
21 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
22 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
23 | TriStar Centennial Medical Center | Nashville | Tennessee | United States | 37203-1624 |
24 | Saint Davids South Austin Medical Center | Austin | Texas | United States | 78704 |
25 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
26 | Texas Transplant Institute | San Antonio | Texas | United States | 78229 |
27 | VA Puget Sound Health Care System - NAVREF - PPDS | Seattle | Washington | United States | 98108 |
28 | The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | United States | 53226 |
29 | Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
30 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
31 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
32 | Medizinische Universitat Wien (Medical University of Vienna) | Vienna | Wien | Austria | |
33 | Elisabethinen Hospital Linz | Linz | Austria | 4020 | |
34 | UZ Antwerpen | Edegem | Antwerpen | Belgium | 2650 |
35 | Institute Jules Bordet | Bruxelles | Brussels | Belgium | 1000 |
36 | Cliniques Universitaires Saint-Luc | Bruxelles | Brussels | Belgium | 1200 |
37 | Universitair Ziekenhuis Brussel - PIN | Jette | Brussels | Belgium | 1090 |
38 | University Hospital Gent | Gent | Oost-Vlaanderen | Belgium | 9000 |
39 | UZ Leuven | Leuven | Vlaams Brabant | Belgium | 3000 |
40 | AZ Sint-Jan AV | Brugge | West-Vlaanderen | Belgium | 8000 |
41 | CHU de Liège | Liège | Belgium | 4000 | |
42 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
43 | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | Canada | B3H 2Y9 |
44 | Hamilton Health Sciences Corporation | Hamilton | Ontario | Canada | L8N 3Z5 |
45 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
46 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
47 | Nanfang Hospital Southern Medical University | Guangzhou | Guangdong | China | 510515 |
48 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
49 | Xiangya Hospital Central South University | Changsha | China | 410008 | |
50 | Guangzhou First People's Hospital | Guangzhou | China | 510180 | |
51 | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou Zhejiang | China | 310003 | |
52 | Henan Cancer Hospital | Zhengzhou | China | 450008 | |
53 | University Hospital Center Zagreb | Zagreb | Croatia | 10000 | |
54 | Fakultni nemocnice v Motole | Prague | Praha, Hlavní Mesto | Czechia | 150 00 |
55 | Ustav hematologie a krevni transfuze | Praha | Czechia | 128 20 | |
56 | Institut de Cancérologie Strasbourg Europe | Strasbourg Cedex | Bas-Rhin | France | 67033 |
57 | Hopital de Hautepierre | Strasbourg Cedex | Bas-Rhin | France | 67098 |
58 | CHU de Bordeaux | Pessac | Gironde | France | 33604 |
59 | Hôpital Universitaire Dupuytren | Limoges | Haute-Vienne | France | 87042 |
60 | CHU de GRENOBLE | GRENOBLE Cedex 9 | Isère | France | 38043 |
61 | Hôtel Dieu | Nantes | Loire-Atlantique | France | 44093 |
62 | CHU Angers | Angers Cedex 9 | Maine-et-Loire | France | 49933 |
63 | Hopital Henri Mondor | Créteil | Val-de-Marne | France | 94010 |
64 | Hopital Jean Minjoz | Besnçon | France | 25030 | |
65 | Institut Paoli Calmettes | Nice | France | 7120 | |
66 | Hôpital Saint Antoine | Paris | France | 75012 | |
67 | Hôpital Saint Louis | Paris | France | 75475 | |
68 | EDOG - Institut Claudius Regaud - PPDS | Toulouse cedex 9 | France | 31059 | |
69 | Universitätsklinikum Münster | Muenster | Nordrhein-Westfalen | Germany | 48149 |
70 | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Rheinland-Pfalz | Germany | 55131 |
71 | Universität des Saarlandes | Homburg | Saarland | Germany | 66424 |
72 | Universitatsklinikum Leipzig | Leipzig | Sachsen | Germany | 04103 |
73 | Universitätsklinikum Augsburg | Augsburg | Germany | 86156 | |
74 | Helios Klinikum Berlin-Buch | Berlin | Germany | 13125 | |
75 | Martin Luther Universitat Halle Wittenberg | Halle | Germany | 6120 | |
76 | Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany | 20251 | |
77 | Universitätsklinik Rostock | Rostock | Germany | ||
78 | Robert Bosch Krankenhaus | Stuttgart | Germany | 70376 | |
79 | Universitätsklinikum Tübingen | Tübingen | Germany | 72076 | |
80 | Attikon University General Hospital | Athina | Attiki | Greece | 124 64 |
81 | Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | Greece | 57010 | |
82 | Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet | Budapest | Hungary | 1097 | |
83 | Sheba Medical Center - PPDS | Ramat Gan | HaMerkaz | Israel | 5262000 |
84 | Hadassah Medical Center - PPDS | Jerusalem | Yerushalayim | Israel | 90000 |
85 | Rambam Medical Center - PPDS | Haifa | Israel | 31999 | |
86 | Tel Aviv Sourasky Medical Center PPDS | Tel-Aviv | Israel | 64239 | |
87 | Ospedale Dell'Angelo | Brescia | Lombardia | Italy | 30174 |
88 | Ospedale Infantile Regina Margherita - INCIPIT - PIN | Torino | Piemonte | Italy | 10126 |
89 | Azienda Ospedaliera Universitaria Integrata Di Verona | Verona | Veneto | Italy | 37134 |
90 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50134 | |
91 | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
92 | Fondazione Policlinico Universitario A Gemelli | Roma | Italy | 00168 | |
93 | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy | 10126 | |
94 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
95 | Keimyung University Dongsan Hospital | Daegu | Korea, Republic of | 41931 | |
96 | Auckland City Hospital | Grafton | Auckland | New Zealand | 1023 |
97 | Canterbury Health Laboratories | Christchurch | South Island | New Zealand | 8011 |
98 | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Dolnoslaskie | Poland | 50-367 |
99 | MTZ Clinical Research Sp z o o - PRATIA - PPDS | Warszawa | Mazowieckie | Poland | 02-106 |
100 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-214 | |
101 | First St. Petersburg State Medical University n.a. I.P Pavlov | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197022 |
102 | Regional Oncology Center | Irkutsk | Russian Federation | 664035 | |
103 | Kirov Research Institute of Haematology and Blood Transfusion | Kirov | Russian Federation | 610027 | |
104 | National University Hospital | Singapore | Singapore | 119228 | |
105 | Singapore General Hospital (SGH) | Singapore | Singapore | 169608 | |
106 | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
107 | Hospital Universitario Marques de Valdecilla | Santander | Cantabria | Spain | 39008 |
108 | Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca | Castilla Y León | Spain | 37007 |
109 | Hospital Universitario Vall d'Hebrón - PPDS | Barcelona | Spain | 08035 | |
110 | ICO l'Hospitalet Hospital Duran i Reynals | Barcelona | Spain | 08908- | |
111 | C.H. Regional Reina Sofia - PPDS | Cordoba | Spain | 14004 | |
112 | Hospital Universitario Virgen de Las Nieves | Granada | Spain | 18014 | |
113 | Hospital Universitario de La Princesa | Madrid | Spain | 28006 | |
114 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
115 | Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | Spain | 28222 | |
116 | Hospital Regional Universitario de Malaga - Hospital General | Málaga | Spain | 29010 | |
117 | Hospital Universitario de Donostia | San Sebastian Gipuzkoa | Spain | 20014 | |
118 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
119 | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | 46026 | |
120 | Universitätsspital Zürich | Zurich | Switzerland | 8091 | |
121 | Baskent University Medical Faculty Adana Practice and Research Center | Adana | Turkey | 1250 | |
122 | Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS | Ankara | Turkey | 06590 | |
123 | Birmingham Heartlands Hospital | West Midlands | Birmingham | United Kingdom | B9 5SS |
124 | Hammersmith Hospital | London | London, City Of | United Kingdom | W12 0HS |
125 | University College London | London | London, City Of | United Kingdom | WC1E 6BT |
126 | St George's Hospital | Tooting | London | United Kingdom | SW17 0QT |
127 | Clatterbridge Cancer Centre Liverpool | Liverpool | Merseyside | United Kingdom | L7 8XP |
128 | The Christie NHS Foundation Trust - PPDS | Manchester | United Kingdom | M20 4BX | |
129 | Southampton University Hospitals NHS Trust | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Shire
- Takeda Development Center Americas, Inc.
Investigators
- Study Director: Study Director, Shire
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SHP620-302
- 2015-004726-34