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A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Cytomegalovirus Infections

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Trial Information

A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

Inclusion Criteria


Inclusion Criteria

1. Be ≥12 years of age.

2. Weigh ≥ 40 kg.

3. Be a recipient of stem cell or solid organ transplantation.

4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000
DNA copies/mL.

5. Have a current CMV infection that is resistant (known CMV genetic mutations) or
refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir
and/or foscarnet.

6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy
test prior to randomization.

7. Be able to swallow tablets.

8. If adult, provide written informed consent. If child (age <18 years), have a
parent/legal guardian who is willing and able to provide written informed consent
(with assent from the child when appropriate).

Exclusion Criteria

1. Be receiving any other anti-CMV agent(s).

2. Have a current CMV infection that is considered resistant or refractory due to
inadequate adherence to prior oral anti-CMV treatment.

3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24
hours prior to the time of enrollment.

4. Have severe hepatic impairment.

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

6. Have expected survival less than 6 weeks.

7. Be pregnant or breastfeeding.

8. Other clinically significant medical or surgical condition.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of subjects with treatment emergent adverse events.

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Stephen A. Villano, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

ViroPharma Incorporated

Authority:

United States: Food and Drug Administration

Study ID:

1263-202

NCT ID:

NCT01611974

Start Date:

July 2012

Completion Date:

November 2014

Related Keywords:

  • Cytomegalovirus Infections
  • CMV
  • cytomegalovirus
  • resistant
  • refractory
  • transplant
  • treatment
  • Cytomegalovirus Infections

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Brigham and Women's HospitalBoston, Massachusetts  02115
University of ColoradoDenver, Colorado  80217
University of MinnesotaMinneapolis, Minnesota  55455
University of WashingtonSeattle, Washington  98195
Columbia UniversityNew York, New York  10032-3784
Duke UniversityDurham, North Carolina  27710
University of UtahSalt Lake City, Utah  
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Oregon Health & Science UniversityPortland, Oregon  97201
Northwestern UniversityChicago, Illinois  60611
University of FloridaGainesville, Florida  32610-0277
Emory UniversityAtlanta, Georgia  30322
Cleveland ClinicCleveland, Ohio  44195
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
UCLA Medical CenterLos Angeles, California  90095-7059
University of ChicagoChicago, Illinois  60637
Tampa General HospitalTampa, Florida  33606
Johns HopkinsBaltimore, Maryland  21231
University of Pittsburg Medical CenterPittsburg, Pennsylvania  15213
Nationwide Childrens HospitalColumbus, Ohio  
VanderbiltAtlanta, Georgia  37212
University of MassachesettsWorcester, Massachusetts  01655
Henry Ford Health Care SystemDetroit, Michigan  
University of Nebraska Medica CenterOmaha, Nebraska  68198