Efficacy and Safety of Maribavir in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment

Description

The purpose of this study is to determine if an investigational treatment (Maribavir) is safe and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections that are refractory or resistant to treatment.

Study Start Date

December, 01 2016

Estimated Completion Date

May 2019

Interventions

  • Drug: Investigator-Assigned Treatment
  • Drug: Maribavir

Study ID

Shire -- SHP620-303

Status

Recruiting

Trial ID

NCT02931539

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

351

Sponsor

Shire

Inclusion Criteria

    1. The subject 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 subject before completing any study-related procedures. 2. The subject must be a recipient of hematopoietic stem cell or solid organ transplant. 3. The subject must have a documented CMV infection greater than or equal to ? 910 IU/ml in blood or plasma samples, from two consecutive assessments separated by at least one day, taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. 4. The subject must have a current CMV infection refractory or resistant to treatment. Refractory is defined as failure to have greater than (>)1 log10 decrease in CMV viral load within minimum of 2 weeks of treatment with ganciclovir, valganciclovir, foscarnet or cidofovir . 5. The Investigator must be willing to treat the subject 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 subject must be ?12 years of age at the time of consent 7. The subject must weigh ?35 kilogram (kg). 8. The subject 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 109^9/L] 2. Platelet count ? 25,000/mm^3 [25 x 10^9/L], 3. Hemoglobin ? 8 gram per deciliter (g/dL). 4. Estimated glomerular filtration rate (eGFR) >30 (milliliter per minute (mL/min) /1.73 meter square (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for subjects ?18 years of age or Schwartz formula for subjects less than (<)18 years of age. 9. The subject must have a negative 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 subject must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube. 11. The subject must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol. 12. The subject 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 subject 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 NOTE: A subject who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study must discontinue their use before the first dose of study drug. If subject is currently receiving cidofovir and is assigned another anti-CMV agent by the investigator the subject 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, or artesunate when study treatment is initiated. NOTE: Subjects 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. Subjects 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. 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. Subjects with CMV hepatitis will not be excluded despite having >5 times ULN at screening. 8. Have known (previously documented) positive results for human immunodeficiency virus (HIV). 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. Subjects 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 subject.

Gender

All

Ages

12 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (105)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Francisco Marty 617-732-8881 fmarty@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles David Wojciechowski 617-724-9673 dwojciechowski@mgh.harvard.edu
Columbia University Medical Center - New York, New York 181.2 miles Marcus Pereira 212-305-7185 mp2323@columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Marcus Pereira 212-305-7185 mp2323@columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Marcus Pereira 212-305-7185 mp2323@columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Marcus Pereira 212-305-7185 mp2323@columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Marcus Pereira 212-305-7185 mp2323@columbia.edu
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Avery MD 443-287-4694 ravery4@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Avery MD 443-287-4694 ravery4@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Avery MD 443-287-4694 ravery4@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Avery MD 443-287-4694 ravery4@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Robin Avery MD 443-287-4694 ravery4@jhmi.edu
University of Maryland - Baltimore, Maryland 358.9 miles Abdolreza Haririan 410-328-5720 ahariria@som.umaryland.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles Fernanda Silveira 412-647-0996 silveirafd@upmc.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles Fernanda Silveira 412-647-0996 silveirafd@upmc.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles Fernanda Silveira 412-647-0996 silveirafd@upmc.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles Fernanda Silveira 412-647-0996 silveirafd@upmc.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles Fernanda Silveira 412-647-0996 silveirafd@upmc.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Barbara Alexander 919-668-0789 barbara.alexander@dm.duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Barbara Alexander 919-668-0789 barbara.alexander@dm.duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Barbara Alexander 919-668-0789 barbara.alexander@dm.duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Barbara Alexander 919-668-0789 barbara.alexander@dm.duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Barbara Alexander 919-668-0789 barbara.alexander@dm.duke.edu
Henry Ford Hospital - Detroit, Michigan 612.3 miles George Alangaden 313-916-2573 galanga1@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles George Alangaden 313-916-2573 galanga1@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles George Alangaden 313-916-2573 galanga1@hfhs.org
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Dilip Samarapungavan MD 248-551-2594 dilip.samarapungavan@beaumont.edu
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Dilip Samarapungavan MD 248-551-2594 dilip.samarapungavan@beaumont.edu
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Dilip Samarapungavan MD 248-551-2594 dilip.samarapungavan@beaumont.edu
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Dilip Samarapungavan MD 248-551-2594 dilip.samarapungavan@beaumont.edu
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Dilip Samarapungavan MD 248-551-2594 dilip.samarapungavan@beaumont.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Vinayak Rohan 843-792-4003 rohanv@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Vinayak Rohan 843-792-4003 rohanv@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Vinayak Rohan 843-792-4003 rohanv@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Vinayak Rohan 843-792-4003 rohanv@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Vinayak Rohan 843-792-4003 rohanv@musc.edu
Feinberg School of Medicine - Chicago, Illinois 847.9 miles Michael Ison MD 312-695-4186 mgison@northwestern.edu
Feinberg School of Medicine - Chicago, Illinois 847.9 miles Michael Ison MD 312-695-4186 mgison@northwestern.edu
Feinberg School of Medicine - Chicago, Illinois 847.9 miles Michael Ison MD 312-695-4186 mgison@northwestern.edu
Feinberg School of Medicine - Chicago, Illinois 847.9 miles Michael Ison MD 312-695-4186 mgison@northwestern.edu
Feinberg School of Medicine - Chicago, Illinois 847.9 miles Michael Ison MD 312-695-4186 mgison@northwestern.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Nina Clark MD 708-216-3135 nmclark@lumc.edu
University of Chicago Medical Center - Chicago, Illinois 859.6 miles Kathleen Mullane DO PharmD 773-702-3756 kmullane@medicine.bsd.uchicago.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Nina Clark MD 708-216-3135 nmclark@lumc.edu
University of Chicago Medical Center - Chicago, Illinois 859.6 miles Kathleen Mullane DO PharmD 773-702-3756 kmullane@medicine.bsd.uchicago.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Nina Clark MD 708-216-3135 nmclark@lumc.edu
University of Chicago Medical Center - Chicago, Illinois 859.6 miles Kathleen Mullane DO PharmD 773-702-3756 kmullane@medicine.bsd.uchicago.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Nina Clark MD 708-216-3135 nmclark@lumc.edu
University of Chicago Medical Center - Chicago, Illinois 859.6 miles Kathleen Mullane DO PharmD 773-702-3756 kmullane@medicine.bsd.uchicago.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Nina Clark MD 708-216-3135 nmclark@lumc.edu
University of Chicago Medical Center - Chicago, Illinois 859.6 miles Kathleen Mullane DO PharmD 773-702-3756 kmullane@medicine.bsd.uchicago.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uabmc.edu
University of Minnesota - Minneapolis, Minnesota 1,120.4 miles JoAnne Young 612-625-8642 vanbu004@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.4 miles JoAnne Young 612-625-8642 vanbu004@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.4 miles JoAnne Young 612-625-8642 vanbu004@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.4 miles JoAnne Young 612-625-8642 vanbu004@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.4 miles JoAnne Young 612-625-8642 vanbu004@umn.edu
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Diana Florescu MD 402-559-8930 None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Diana Florescu MD 402-559-8930 None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Diana Florescu MD 402-559-8930 None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Diana Florescu MD 402-559-8930 None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Diana Florescu MD 402-559-8930 None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Julia GarciaDiaz 504-842-5748 jgarcia-diaz@ochsner.org
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Julia GarciaDiaz 504-842-5748 jgarcia-diaz@ochsner.org
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Julia GarciaDiaz 504-842-5748 jgarcia-diaz@ochsner.org
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Julia GarciaDiaz 504-842-5748 jgarcia-diaz@ochsner.org
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Julia GarciaDiaz 504-842-5748 jgarcia-diaz@ochsner.org
Baylor College of Medicine - Houston, Texas 1,609.9 miles Ronald Cotton MD 832-355-1400 ronaldc@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Ronald Cotton MD 832-355-1400 ronaldc@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Ronald Cotton MD 832-355-1400 ronaldc@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Ronald Cotton MD 832-355-1400 ronaldc@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Ronald Cotton MD 832-355-1400 ronaldc@bcm.edu
University of Utah Health Sciences Center - Salt Lake City, Utah 2,094.1 miles Fuad Shihab 801-585-3823 fuad.shihab@hsc.utah.edu
University of Utah Health Sciences Center - Salt Lake City, Utah 2,094.1 miles Fuad Shihab 801-585-3823 fuad.shihab@hsc.utah.edu
University of Utah Health Sciences Center - Salt Lake City, Utah 2,094.1 miles Fuad Shihab 801-585-3823 fuad.shihab@hsc.utah.edu
University of Utah Health Sciences Center - Salt Lake City, Utah 2,094.1 miles Fuad Shihab 801-585-3823 fuad.shihab@hsc.utah.edu
University of Utah Health Sciences Center - Salt Lake City, Utah 2,094.1 miles Fuad Shihab 801-585-3823 fuad.shihab@hsc.utah.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable 507-284-3747 razonable.raymund@mayo.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable 507-284-3747 razonable.raymund@mayo.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable 507-284-3747 razonable.raymund@mayo.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable 507-284-3747 razonable.raymund@mayo.edu
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Joshua Hill MD None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Joshua Hill MD None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Joshua Hill MD None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Joshua Hill MD None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Joshua Hill MD None None
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-9264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-9264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-9264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-9264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-9264 dwinston@mednet.ucla.edu

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