Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: HCMV Reactivation or HCMV End-Organ Disease

In brief

The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).

Key facts

Study ID

NCT01063829

Run by

AiCuris Anti-infective Cures AG

People needed

133

Starts

2010-03-01

Expected to finish

2011-12-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Stanford University Hospital — Stanford, California, United States
• Denver St. Lukes Presbyterian — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Indiana BMT — Beech Grove, Indiana, United States
• University Of Iowa — Iowa City, Iowa, United States
• Dana Farber Cancer Institute, — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Jeanes Hospital of TUHS — Philadelphia, Pennsylvania, United States
• UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Universitaetsklinikum Dresden — Dresden, Germany
• Universitaetsklinikum Erlangen-PS — Erlangen, Germany
• Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Universitaeetsklinikum Heidelberg, , — Heidelberg, Germany
• Universitaetsklinikum Mainz — Mainz, Germany
• Universitaetsklinikum Muenster — Münster, Germany
• Klinikum Nuernberg Nord — Nuremberg, Germany
• Robert-Bosch-Krankenhaus — Stuttgart, Germany
• Universitaetsklinikum Wuerzburg — Würzburg, Germany

Full record on ClinicalTrials.gov

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