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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01063829
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH

Study Description
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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).

Condition or disease Intervention/treatment Phase
HCMV Reactivation or HCMV End-Organ Disease Drug: 60 mg AIC246 Drug: 120 mg AIC246 Drug: 240 mg AIC246 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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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
Placebo
Placebo arm
 Other: Placebo
Oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]
  2. Time to Onset of "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]

Secondary Outcome Measures :
  1. Number of Patients With Systemic Detectable HCMV Replication. [ Time Frame: 84 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063829


Locations
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Sponsors and Collaborators
AiCuris Anti-infective Cures GmbH
Quintiles, Inc.
More Information
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Additional Information:

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

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Responsible Party: AiCuris Anti-infective Cures GmbH
ClinicalTrials.gov Identifier: NCT01063829    
Other Study ID Numbers: AIC246-01-II-02
First Posted: February 5, 2010    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: December 2010
Keywords provided by AiCuris Anti-infective Cures GmbH:
HCMV