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

Phase 2

Completed

• Conditions: HCMV Reactivation or HCMV End-Organ Disease
• Interventions: Drug: 60 mg AIC246; Drug: 120 mg AIC246; Drug: 240 mg AIC246; Other: Placebo

• Registration Number: NCT01063829
• Lead Sponsor: AiCuris Anti-infective Cures AG

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Study Start: 2010-03
• Status Verified: 2010-12
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Disposition First Submitted: 2013-01-24
• Disposition First Submitted QC: 2013-01-28
• Disposition First Posted: 2013-01-30
• Results First Submitted: 2017-12-06
• Results First Submitted QC: 2018-01-15
• Last Update Submitted: 2018-01-15
• Results First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose regimen 1	60 mg AIC246	60 mg AIC246, one tablet per day
Dose regimen 2	120 mg AIC246	120 mg AIC246, one tablet per day
Dose regimen 3	240 mg AIC246	240 mg AIC246, one tablet per day
Placebo	Placebo	Placebo arm

Primary Outcome Measures

Name	Time	Method
Number of Participants With "HCMV Prophylaxis Failure"	84 days
Time to Onset of "HCMV Prophylaxis Failure"	84 days

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Systemic Detectable HCMV Replication.	84 days

Trial Locations

Locations (24)

UPMC Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Universitaetsklinikum Erlangen-PS; 🇩🇪 Erlangen,, Germany

Universitaetsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Loyola University Chicago; 🇺🇸 Maywood, Illinois, United States

Stanford University Hospital; 🇺🇸 Stanford, California, United States

Klinikum Nuernberg Nord; 🇩🇪 Nuernberg, Germany

Universitaetsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitaeetsklinikum Heidelberg, ,; 🇩🇪 Heidelberg, Germany

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Indiana BMT; 🇺🇸 Beech Grove, Indiana, United States

Jeanes Hospital of TUHS; 🇺🇸 Philadelphia, Pennsylvania, United States

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitaetsklinikum Mainz; 🇩🇪 Mainz, Germany

Universitaetsklinikum Wuerzburg; 🇩🇪 Würzburg, Germany

Universitaetsklinikum Muenster; 🇩🇪 Muenster, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

University Of Iowa; 🇺🇸 Iowa City, Iowa, United States

Denver St. Lukes Presbyterian; 🇺🇸 Denver, Colorado, United States

Dana Farber Cancer Institute,; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States