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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 Michigan Ann Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
Medical University of South Carolina Charleston, South Carolina  29425-0721
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Brigham and Women's Hospital Boston, Massachusetts  02115
University of Colorado Denver, Colorado  80217
University of Minnesota Minneapolis, Minnesota  55455
University of Washington Seattle, Washington  98195
Columbia University New York, New York  10032-3784
Duke University Durham, North Carolina  27710
University of Utah Salt Lake City, Utah  
University of Pennsylvania Philadelphia, Pennsylvania  19104
Oregon Health & Science University Portland, Oregon  97201
Northwestern University Chicago, Illinois  60611
University of Florida Gainesville, Florida  32610-0277
Emory University Atlanta, Georgia  30322
Cleveland Clinic Cleveland, Ohio  44195
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
UCLA Medical Center Los Angeles, California  90095-7059
University of Chicago Chicago, Illinois  60637
Tampa General Hospital Tampa, Florida  33606
Johns Hopkins Baltimore, Maryland  21231
University of Pittsburg Medical Center Pittsburg, Pennsylvania  15213
Nationwide Childrens Hospital Columbus, Ohio  
Vanderbilt Atlanta, Georgia  37212
University of Massachesetts Worcester, Massachusetts  01655
Henry Ford Health Care System Detroit, Michigan  
University of Nebraska Medica Center Omaha, Nebraska  68198