Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
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
1 other identifier
interventional
133
2 countries
24
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
February 13, 2018
CompletedFebruary 13, 2018
December 1, 2010
1.6 years
February 4, 2010
December 6, 2017
January 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With "HCMV Prophylaxis Failure"
84 days
Time to Onset of "HCMV Prophylaxis Failure"
84 days
Secondary Outcomes (1)
Number of Patients With Systemic Detectable HCMV Replication.
84 days
Study Arms (4)
Dose regimen 1
EXPERIMENTAL60 mg AIC246, one tablet per day
Dose regimen 2
EXPERIMENTAL120 mg AIC246, one tablet per day
Dose regimen 3
EXPERIMENTAL240 mg AIC246, one tablet per day
Placebo
OTHERPlacebo arm
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AiCuris Anti-infective Cures AGlead
- Quintiles, Inc.collaborator
Study Sites (24)
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
Related Publications (1)
Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhauser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kolling K, Stobernack HP, Lischka P, Zimmermann H, Rubsamen-Schaeff H, Champlin RE, Ehninger G; AIC246 Study Team. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med. 2014 May 8;370(19):1781-9. doi: 10.1056/NEJMoa1309533.
PMID: 24806159DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- AiCuris Anti-infective Cures GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
February 13, 2018
Results First Posted
February 13, 2018
Record last verified: 2010-12