A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02927067
• Collaborator: Takeda Development Center Americas, Inc. (Industry)
• Enrollment: 553
• Locations: 129
• Arms: 2
• Actual Duration (Months): 62.2
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.1

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
Cytomegalovirus (CMV)	Drug: Maribavir; Drug: Valganciclovir; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 553 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
• Actual Study Start Date: Apr 14, 2017
• Actual Primary Completion Date: Jun 19, 2022
• Actual Study Completion Date: Jun 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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).

8. Predose Concentration (Cmin) of Maribavir [Weeks 1, 4, and 8: pre-morning dose]

9. 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]

10. 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]

11. 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]

12. 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]

13. 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

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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).

• Be greater than or equal to (>=) 16 years of age at the time of consent.

• Be a recipient of hematopoietic stem cell transplant.

• 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:

1. 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,

2. Haploidentical donor

3. Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,

4. Use of umbilical cord blood as stem cell source,

5. Use of ex vivo T-cell-depleted grafts,

6. 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).

• 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.

• Per investigator's judgment, be eligible for treatment with valganciclovir.

• 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):

1. Absolute neutrophil count to >=1000 per cubic millimeter (/mm^{3) [1.0*10}9/L].

2. Platelet count >=25,000/mm^{3 [25*10}9/L].

3. Hemoglobin >=8 grams per deciliter (g/dL).

4. Estimated creatinine clearance >=30 milliliters per minute (mL/min).

• 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.

• Be able to swallow tablets.

• Have life expectancy of >=8 weeks.

• Weigh >=40 kilograms (kg).

• Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.

Exclusion Criteria:

• Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.

• Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.

• 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.

• 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.

• 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.

• Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.

• Have known hypersensitivity to the active substance or to an excipient of the study treatments.

• 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.

• Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.

• Be female and pregnant or nursing.

• Have previously completed, discontinued, or have been withdrawn from this study.

• Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.

• Have received any unapproved agent or device within 30 days before initiation of study treatment.

• 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.

• Have previously received maribavir.

• 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.

• 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.

• 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.

• Be undergoing treatment for acute or chronic hepatitis C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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:

• To obtain more information on the study, click here/on this link

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT02927067
• Other Study ID Numbers: SHP620-302; 2015-004726-34
• First Posted: Oct 6, 2016
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cytomegalovirus Infections; Valganciclovir; Maribavir

Study Results

No Results Posted as of Jul 6, 2022