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MARIBELNCT06677892

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium

StatusCompleted
PhaseNot specified
SponsorTakeda
Primary completion
Track this trial

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 8 entries
    • Eligibility criteria expanded, about 5 words
    • Trial completed
    • Study completion date changed from estimate of Sep 30, 2026 to Oct 28, 2026
  2. Study completion date: Sep 1, 2026 to Sep 30, 2026v7
  3. Enrollment closed, study ongoing
    • Enrollment reduced: 75 → 66 participants
    • Site details revised at 9 of 9 sites
    v6
  4. Site contacts updated at 1 of 9 sitesv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    • Start date changed from estimate of Jan 15, 2025 to Feb 24, 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Dec 1, 2024 to Jan 15, 2025v3
  2. Study Status, Outcome Measures, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
Timeframe: Up to 16 weeks
Duration of Treatment
Timeframe: From treatment start to discontinuation of maribavir (up to 16 weeks)
Time to Viral Clearance
Timeframe: From treatment start to achievement of viral clearance (up to 2 years)
Percentage of Participants With Drug Resistance
Timeframe: Up to 2 years
Number of Participants With Use of Maribavir in Daily Clinical Practice
Timeframe: Up to 16 weeks
Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment
Timeframe: Up to 16 weeks
Percentage of Participants With Recurrence After Maribavir Treatment
Timeframe: Up to 2 years
Number of Participants With Treatment Related Adverse Events (AEs)
Timeframe: Up to 2 years

Arms and interventions

All Participants

Participants with post-transplant CMV infection and/or disease that are refractory or intolerant to one or more prior therapies, who have undergone a solid organ transplant/ hematopoietic stem-cell transplantation (SOT/HSCT) and are treated with maribavir for the first time and in line with the Belgian reimbursement criteria, data will be collected and observed prospectively for up to 2 years.

Other: No Intervention

Sites

9 sites in 1 country