Janice Brown
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: maribavir
- Drug: placebo
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Allogeneic stem cell transplant recipient
- Recipient or donor CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
Key Exclusion Criteria:
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
Additional Study Details
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.Anticipated start date:
5/30/2007Lead Sponsor:
Viropharma Inc.Investigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- CMV organ disease [ Time Frame: 6 months post-transplant ]
Secondary Outcomes:
- CMV organ disease [ Time Frame: 100 days and 12 months post-transplant ]
- Incidence of CMV infection [ Time Frame: 100 days, 6 months, and 12 months post-transplant ]
- Incidence of graft-versus-host disease [ Time Frame: 100 days and 6 months post-transplant ]
- Mortality [ Time Frame: 100 days, 6 months, and 12 months post-transplant ]
Total Number to be Enrolled:
500Total Number to be Enrolled at Stanford:
8More Information
Secondary ID(s):
- 97548
- BMT192
- NCT00411645
- VP 1263-300
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/22/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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