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

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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

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 5, 2010
Results First Submitted Date  ICMJE December 6, 2017
Results First Posted Date  ICMJE February 13, 2018
Last Update Posted Date February 13, 2018
Study Start Date  ICMJE March 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Number of Participants With "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]
  • Time to Onset of "HCMV Prophylaxis Failure" [ Time Frame: 84 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
HCMV reactivation or HCMV End-Organ Disease [ Time Frame: 92 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
Number of Patients With Systemic Detectable HCMV Replication. [ Time Frame: 84 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HCMV Reactivation or HCMV End-Organ Disease
Intervention  ICMJE
  • Drug: 60 mg AIC246
    Oral administration
  • Drug: 120 mg AIC246
    Oral administration
  • Drug: 240 mg AIC246
    Oral administration
  • Other: Placebo
    Oral administration
Study Arms  ICMJE
  • Experimental: Dose regimen 1
    60 mg AIC246, one tablet per day
    Intervention: Drug: 60 mg AIC246
  • Experimental: Dose regimen 2
    120 mg AIC246, one tablet per day
    Intervention: Drug: 120 mg AIC246
  • Experimental: Dose regimen 3
    240 mg AIC246, one tablet per day
    Intervention: Drug: 240 mg AIC246
  • Placebo
    Placebo arm
    Intervention: Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
133
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2010)
132
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01063829
Other Study ID Numbers  ICMJE AIC246-01-II-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AiCuris Anti-infective Cures GmbH
Study Sponsor  ICMJE AiCuris Anti-infective Cures GmbH
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE Not Provided
PRS Account AiCuris Anti-infective Cures GmbH
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP