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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01063829
First received: February 4, 2010
Last updated: January 28, 2013
Last verified: December 2010
  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):
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 October 23, 2014