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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
Not Enrolling
Both
Cytomegalovirus

Thank you

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 IowaIowa City, Iowa  52242
MD Anderson Cancer CenterHouston, Texas  77030-4096
University of MinnesotaMinneapolis, Minnesota  55455
University of FloridaGainesville, Florida  32610-0277
University of Chicago Medical CenterChicago, Illinois  60637
UCLA Medical CenterLos Angeles, California  90095-7059
Karmanos Cancer InstituteDetroit, Michigan  48201
Stanford University HospitalStanford, California  94303
Indiana BMTBeech Grove, Indiana  46107
Loyola University ChicagoMaywood, Illinois  60153
UPMC Cancer CenterPittsburgh, Pennsylvania  15232
Denver St. Lukes PresbyterianDenver, Colorado  
Dana Farber Cancer Institute,Boston, Massachusetts  
Jeanes Hospital of TUHSPhiladelphia, Pennsylvania