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

Trial ID or NCT#

NCT01063829

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Wes (Janice) Brown
Wes (Janice) Brown
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Infectious disease doctor
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

BMT Referrals
650-723-0822

View on ClinicalTrials.gov