A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cytomegalovirus
Both
Cytomegalovirus
Trial Information
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
Inclusion Criteria:
- Seropositive for HCMV IgG antibodies before transplantation
- First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of
the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's
lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
- Evidence of post transplantation engraftment
- Able to swallow tablets.
Exclusion Criteria:
- Previous anti-HCMV therapy after this allogeneic HBPC transplantation
- Mismatched or cord blood transplant recipients
- Current or history of end-organ HCMV disease
- Graft versus host disease (GVHD)
- Impaired liver function
- Reduced renal function
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
HCMV reactivation or HCMV End-Organ Disease
Outcome Time Frame:
92 days
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
AIC246-01-II-02
NCT ID:
NCT01063829
Start Date:
February 2010
Completion Date:
December 2011
Related Keywords:
- Cytomegalovirus
- HCMV
Name | Location |
|---|---|
| University of Iowa | Iowa City, Iowa 52242 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| University of Florida | Gainesville, Florida 32610-0277 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Stanford University Hospital | Stanford, California 94303 |
| Indiana BMT | Beech Grove, Indiana 46107 |
| Loyola University Chicago | Maywood, Illinois 60153 |
| UPMC Cancer Center | Pittsburgh, Pennsylvania 15232 |
| Denver St. Lukes Presbyterian | Denver, Colorado |
| Dana Farber Cancer Institute, | Boston, Massachusetts |
| Jeanes Hospital of TUHS | Philadelphia, Pennsylvania |
