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Complete title: 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 Recipient
|Research Study Number||2601.00|
|Principal Investigator||Michael Boeckh, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 1.Be = or>12 years of age.
- 2.Weigh = or > 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 = or >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).
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Solid Tumors; Cytomegalovirus (CMV)
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