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

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).

Condition	Intervention	Phase
Cytomegalovirus	Drug: AIC246 Other: Placebo	Phase 2


Study Type:	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
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

Further study details as provided by AiCuris GmbH & Co.KG:

Primary Outcome Measures:

HCMV reactivation or HCMV End-Organ Disease [ Time Frame: 92 days ] [ Designated as safety issue: No ]


Enrollment:	133
Study Start Date:	February 2010
Study Completion Date:	December 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dose regimen 1 AIC246	Drug: AIC246 Oral administration
Experimental: Dose regimen 2 AIC246	Drug: AIC246 Oral administration
Experimental: Dose regimen 3 AIC246	Drug: AIC246 Oral administration
Placebo Placebo arm	Other: Placebo Oral administration

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063829

Locations


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

Sponsors and Collaborators

AiCuris GmbH & Co.KG

Quintiles

More Information

No publications provided by AiCuris GmbH & Co.KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhäuser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kölling K, Stobernack HP, Lischka P, Zimmermann H, Rübsamen-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.


Responsible Party:	AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:	NCT01063829 History of Changes
Other Study ID Numbers:	AIC246-01-II-02
Study First Received:	February 4, 2010
Last Updated:	January 28, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AiCuris GmbH & Co.KG:


HCMV

ClinicalTrials.gov processed this record on February 27, 2015