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

January 15, 2018 updated by: AiCuris Anti-infective Cures AG

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose regimen 1
60 mg AIC246, one tablet per day
Drug: 60 mg AIC246
Oral administration
Experimental: Dose regimen 2
120 mg AIC246, one tablet per day
Drug: 120 mg AIC246
Oral administration
Experimental: Dose regimen 3
240 mg AIC246, one tablet per day
Drug: 240 mg AIC246
Oral administration
Other: Placebo
Placebo arm
Other: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With "HCMV Prophylaxis Failure"
Time Frame: 84 days
84 days
Time to Onset of "HCMV Prophylaxis Failure"
Time Frame: 84 days
84 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Systemic Detectable HCMV Replication.
Time Frame: 84 days
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AiCuris Anti-infective Cures AG

Collaborators

Quintiles, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIC246-01-II-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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