Clinical trial NCT01063829: Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HCMV Reactivation or HCMV End-Organ Disease
Keywords: HCMV
Lead sponsor: AiCuris Anti-infective Cures AG
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2010-02-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With "HCMV Prophylaxis Failure"
timeFrame: 84 days
measure: Time to Onset of "HCMV Prophylaxis Failure"
timeFrame: 84 days
Secondary outcomes:
measure: Number of Patients With Systemic Detectable HCMV Replication.
timeFrame: 84 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Denver
country: United States
facility: Denver St. Lukes Presbyterian
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Beech Grove
country: United States
facility: Indiana BMT
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa
state: Iowa
city: Boston
country: United States
facility: Dana Farber Cancer Institute,
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: Jeanes Hospital of TUHS
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Erlangen,
country: Germany
facility: Universitaetsklinikum Erlangen-PS
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitaeetsklinikum Heidelberg, ,
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Nord
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
Study officials:
References:
citation: 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.