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Bone Marrow Transplant

Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients (2601)
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
Status Conditions Phase Study ID
Recruiting Cytomegalovirus (CMV) Phase II 2601
NCT01611974
Summary

This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.


Investigator
Michael Boeckh, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  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).
Exclusions (conditions that would prevent participation in this study)
  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.
Last Updated
February 28, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.