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

• 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: AiCuris Anti-infective Cures GmbH
• Collaborator: Quintiles, Inc.
• Information provided by (Responsible Party): AiCuris Anti-infective Cures GmbH

Tracking Information

• First Submitted Date: February 4, 2010
• First Posted Date: February 5, 2010
• Results First Submitted Date: December 6, 2017
• Results First Posted Date: February 13, 2018
• Last Update Posted Date: February 13, 2018
• Study Start Date: March 2010
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 4, 2010): HCMV reactivation or HCMV End-Organ Disease [ Time Frame: 92 days ]
• Current Secondary Outcome Measures (submitted: January 15, 2018): Number of Patients With Systemic Detectable HCMV Replication. [ Time Frame: 84 days ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: HCMV Reactivation or HCMV End-Organ Disease

Intervention

• Drug: 60 mg AIC246
  Oral administration
• Drug: 120 mg AIC246
  Oral administration
• Drug: 240 mg AIC246
  Oral administration
• Other: Placebo
  Oral administration

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2012): 133
• Original Estimated Enrollment (submitted: February 4, 2010): 132
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, United States

Administrative Information

• NCT Number: NCT01063829
• Other Study ID Numbers: AIC246-01-II-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AiCuris Anti-infective Cures GmbH
• Study Sponsor: AiCuris Anti-infective Cures GmbH
• Collaborators: Quintiles, Inc.
• Investigators: Not Provided
• PRS Account: AiCuris Anti-infective Cures GmbH
• Verification Date: December 2010