Maribavir for Prevention of CMV After Stem Cell Transplants

• ClinicalTrials.gov Identifier: NCT00223925
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: March 26, 2015
• Sponsor: Shire
• Information provided by (Responsible Party): Shire

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: March 26, 2015
• Study Start Date: October 2004
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 25, 2015): Clinical safety as measured by the recording of treatment emergent adverse events [ Time Frame: 13 weeks ]

Original Primary Outcome Measures (submitted: September 13, 2005)

• Safety and tolerabilty for up to 12 weeks of dosing
• Incidence of CMV infection

Current Secondary Outcome Measures (submitted: March 25, 2015)

• Incidence of CMV disease [ Time Frame: 13 weeks ]
• Incidence of CMV infection [ Time Frame: 13 weeks ]

• Original Secondary Outcome Measures (submitted: September 13, 2005): Incidence of CMV disease
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Maribavir for Prevention of CMV After Stem Cell Transplants
• Official Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
• Brief Summary: Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
• Condition: Cytomegalovirus Infection

Intervention

• Drug: Maribavir
• Drug: Placebo

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: Maribavir (100 mg twice daily)
  Intervention: Drug: Maribavir
• Experimental: Maribavir (400 mg twice daily)
  Intervention: Drug: Maribavir
• Experimental: Maribavir (400 mg once daily)
  Intervention: Drug: Maribavir

• Publications *: Winston DJ, Young JA, Pullarkat V, Papanicolaou GA, Vij R, Vance E, Alangaden GJ, Chemaly RF, Petersen F, Chao N, Klein J, Sprague K, Villano SA, Boeckh M. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood. 2008 Jun 1;111(11):5403-10. doi: 10.1182/blood-2007-11-121558. Epub 2008 Feb 19.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2015): 111
• Original Enrollment (submitted: September 13, 2005): 108
• Actual Study Completion Date: April 2006
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Allogeneic stem cell transplant recipient
• Recipient CMV seropositive
• Have transplant engraftment
• Able to swallow tablets

Exclusion Criteria:

• CMV organ disease
• HIV infection
• Use of other anti-CMV therapy post-transplant

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: United States

Administrative Information

• NCT Number: NCT00223925
• Other Study ID Numbers: 1263-200
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shire
• Study Sponsor: Shire
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shire
• Verification Date: March 2014