Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir



Status:Recruiting
Healthy:No
Age Range:12 - Any
Updated:1/18/2019
Start Date:December 29, 2016
End Date:May 6, 2019
Contact:Shire Contact
Email:ClinicalTransparency@shire.com
Phone:+1 866 842 5335

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned
anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are
refractory or resistant to prior anti-CMV treatment.


Inclusion Criteria:

1. The participant must 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
participant before completing any study-related procedures.

2. The participant must be a recipient of hematopoietic stem cell or solid organ
transplant.

3. The participant must have a documented CMV infection in whole blood or plasma, with a
screening value of greater than or equal to (>=) 2730 international units per
milliliter (IU/mL) in whole blood or >= 910 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. The same laboratory
and same sample type (whole blood or plasma) must be used for these assessments.

4. The participant must have a current CMV infection that is refractory to the most
recently administered of the four anti-CMV treatment agents. Refractory is defined as
documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10)
decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment
period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV
cidofovir.

a. Participants with documentation of 1 or more CMV genetic mutations associated with
resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet
the definition of refractory CMV infection.

5. The Investigator must be willing to treat the participant with at least one of the
available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note:
Combination therapy with foscarnet and cidofovir is not permitted in the
investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious
nephrotoxicity.

6. The participant must be >= 12 years of age at the time of consent.

7. The participant must weigh >= 35 kilogram (kg).

8. The participant must 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 (ANC) >= 1000/ millimeter cube (mm^3) (1.0 x 10^9/liter
[L])

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

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

4. Estimated glomerular filtration rate (eGFR) > 30 (milliliters per minute (mL/min)
/1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease
(MDRD) formula for participants >= 18 years of age or Schwartz formula for
participants less than (<) 18 years of age.

9. The participant must have a negative serum beta-human chorionic gonadotropin
(beta-HCG) pregnancy test at screening, if a female of child bearing potential.
Additional urine pregnancy tests may be done per institutional requirements. 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 if treated with maribavir,
ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with
foscarnet.

10. The participant must be able to swallow tablets, or receive tablets crushed and/or
dispensed in water via nasogastric or orogastric tube.

11. The participant must be willing and have an understanding and ability to fully comply
with study procedures and restrictions defined in the protocol.

12. The participant must be willing to provide necessary samples (example [e.g,] biopsy)
for the diagnosis of tissue invasive CMV disease at baseline as determined by the
Investigator.

13. The participant must have a life expectancy of >= 8 weeks.

Exclusion Criteria:

1. Have a current CMV infection that is considered refractory or resistant due to
inadequate adherence to prior anti-CMV treatment, to the best knowledge of the
Investigator.

2. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for
conditions other than CMV when study treatment is initiated (example: herpes simplex
virus (HSV) coinfection requiring use of any of these agents after the randomization)
or would need a coadministration with maribavir for CMV infection. NOTE: A participant
who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or
foscarnet) for the study treatment (if randomized to the investigator assigned
anti-CMV treatment arm), must discontinue their use before the first dose of study
drug. If participant is currently being treated with cidofovir and is assigned another
anti-CMV therapy by the investigator, the participant must discontinue its use at
least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study
treatment.

3. Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated.
NOTE: Participants 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 at least 3 days prior to the
first dose of study treatment. Participants receiving artesunate must discontinue the
use prior to the first dose of study treatment.

4. 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/enteral medication.

5. Have known hypersensitivity to the active substance or to an excipient for a study
treatment.

6. Have tissue invasive CMV disease with central nervous system involvement including the
retina (example, CMV retinitis).

7. Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at
screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or
total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome),
by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be
excluded from study participation despite AST or ALT > 5 times ULN at screening.

8. Have known 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.

9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of
enrollment.

10. Be female and pregnant or breast feeding.

11. Have previously received maribavir.

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

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

14. Have active malignancy with the exception of nonmelanoma skin cancer. Participants who
have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or
progression of the malignancy as per investigator's opinion are not to be enrolled.

15. Be undergoing treatment for acute or chronic hepatitis C.

16. Have any clinically significant medical or surgical condition that, in the
investigator's opinion, could interfere with the interpretation of study results,
contraindicate the administration of the assigned study treatment, or compromise the
safety or well-being of the participant.
We found this trial at
48
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Daniel Kaul, MD
Phone: 734-936-5205
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: John Baddley, MD, MSPH
Phone: 205-934-5191
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Wojciechowski, DO
Phone: 617-724-9673
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Francisco Marty, MD
Phone: 617-732-8881
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Lara Danziger-Isakov, MD
Phone: 513-636-9101
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Monica Ardura, DO
Phone: 614-722-4452
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Ronald Cotton, MD
Phone: 832-355-1400
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Emily Blodget, MD
Phone: 323-409-4398
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Ashok Srinivasan, BS, MB, MD
Phone: 901-595-4720
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jo-Anne Young, MD
Phone: 612-625-8642
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Sacramento, California 95814
Principal Investigator: Stuart Cohen, MD
Phone: 916-734-3742
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Joshua Hill, MD
Phone: 206-667-6504
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: George Lyon III, MD
Phone: 404-712-2051
Emory University Hospital As the largest health care system in Georgia and the only health...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Abdolreza Haririan, MD, MPH
Phone: 410-328-5720
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Robin Avery, MD
Phone: 443-287-4694
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
96 Jonathan Lucas Street
Charleston, South Carolina 29425
Principal Investigator: Vinayak Rohan, MD
Phone: 843-792-4003
?
mi
from
Charleston, SC
Click here to add this to my saved trials
303 East Chicago Avenue
Chicago, Illinois 60611
Principal Investigator: Michael Ison, MD
Phone: 312-695-4186
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Ervin Woodle, MD
Phone: 513-584-0985
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Ervin Woodle, MD
Phone: 513-584-0985
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44012
Principal Investigator: Kenneth Chavin, MD, PhD
Phone: 216-844-2858
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Ricardo La Hoz, MD
Phone: 214-645-2800
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: George Alangaden, MD
Phone: 313-916-2573
?
mi
from
Detroit, MI
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Sanjeet Dadwal, MD
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Barbara Alexander, MD
Phone: 919-668-0789
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Bernard Fischbach, MD
Phone: 817-922-7667
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Scott Rowley, MD
Phone: 201-996-3872
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Roy Chemaly, MD
Phone: 713-792-6830
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Principal Investigator: Roberto Gedaly, MD
Phone: 859-323-4661
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Drew Winston, MD
Phone: 310-825-9264
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Nina Clark, MD
Phone: 708-216-3135
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Maywood, Illinois 60153
Principal Investigator: Kathleen Mullane, DO, PharmD
Phone: 773-702-3756
?
mi
from
Maywood, IL
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Maricar Malinis, MD
Phone: 203-785-3561
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
Principal Investigator: Julia Garcia-Diaz, MD
Phone: 504-842-5748
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Genovefa Papanicolaou, MD
Phone: 212-639-8361
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Marcus Pereira, MD
Phone: 212-305-7185
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
Principal Investigator: Catherine Small, MD
Phone: 914-493-8244
?
mi
from
New York, NY
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Diana Florescu, MD
Phone: 402-559-8930
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32804
Principal Investigator: Bobby Nibhanupudy, MD
Phone: 407-303-2474
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Emily Blumberg, MD
Phone: 215-662-7066
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Fernanda Silveira, MD
Phone: 412-647-0996
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Raymund Razonable
Phone: 507-284-3747
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Royal Oak, Michigan 48073
Principal Investigator: Dilip Samarapungavan, MD
Phone: 248-551-2594
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Fuad Shihab, MD
Phone: 801-585-3823
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Janice Brown, MD
Phone: 650-723-0822
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Tirdad Zangeneh
Phone: 520-626-6887
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Valhalla, New York 10595
Principal Investigator: Catherine Small, MD
Phone: 914-493-8244
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
Westmead, New South Wales 2145
Principal Investigator: Philip O'Connell, BS, MB, MD, PhD
Phone: +61298456848
?
mi
from
Westmead,
Click here to add this to my saved trials
Worcester, Massachusetts 01605
Principal Investigator: Laura Gibson, MD
Phone: 508-856-1978
?
mi
from
Worcester, MA
Click here to add this to my saved trials