Trial · NCT05137717
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8 | At Week 8 | The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is \[i.e.\], less than \[\<\] 34.5 international units per milliliter \[IU/mL\]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose of study drug up to Week 20 | A TEAEs was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly / birth defect or was medically important due to other reasons than the above mentioned criteria. |
| Primary | Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir | From first dose of study drug up to Week 20 | The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported. |
| Primary | Number of Participants With Clinically Meaningful Changes in Vital Signs | From first dose of study drug up to Week 20 | Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any clinically meaningful change in vital signs which were deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings | From first dose of study drug up to Week 20 | Physical examination included assessments of the head, eyes, ears, nose, throat, neck, lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Any clinically meaningful change in physical examination which were deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters | From first dose of study drug up to Week 20 | Clinical laboratory parameters included evaluations of hematology, chemistry, urinalysis. Any clinically meaningful change in clinical laboratory parameters which were deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs) | From first dose of study drug up to Week 20 | 12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported. |
| Primary | Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood | From first dose of study drug up to Week 8 | Immunosuppressant drug concentration testing was solely for participants who received immunosuppressive therapy with tacrolimus, cyclosporine, or everolimus. The number of participants with an increased level of at least one immunosuppressant drug was reported. |
| Primary | Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss | From first dose of study drug up to Week 20 | New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported. |
| Secondary | Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20 | At Week 8 through Weeks 12, 16 and 20 | The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the LLOQ (i.e., \<34.5 IU/mL) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. Percentage of participants who maintained combined CMV viremia clearance and CMV infection symptom control at Week 8 Through Weeks 12, 16 and 20 were reported. |
| Secondary | Time to First Confirmed CMV Viremia Clearance | From first dose of study drug up to Week 20 | Time to first confirmed viremia clearance was defined as time from the start date of first dose of study treatment to the date of confirmed viremia clearance (event), or the date of last CMV DNA assessment on study before the initiation of alternative anti-CMV treatment (censored). The time to first confirmed CMV viremia clearance was calculated as date of first confirmed CMV viremia clearance - randomization date + 1). The date of first confirmed CMV viremia clearance was the date of first of two consecutive samples with plasma CMV DNA \<LLOQ that meet the criteria of confirmed CMV viremia clearance. |
| Secondary | Percentage of Participants With Recurrence of Confirmed CMV Viremia During Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 Who Required Additional Anti-CMV Treatment | From Week 9 up to Week 20 | Recurrence of confirmed CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (\>= 34.5 IU/mL) LLOQ when assessed by the COBAS® 8800/COBAS®CMV Test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. |
| Secondary | Change From Baseline in Plasma CMV Viremia Load | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20 | The change from baseline in plasma CMV viral load, i.e., plasma CMV DNA concentration was assessed and reported. |
| Secondary | Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment | Study treatment: Week 0 to Week 8; Follow-up Period:Week 9 to Week 20; At Any time during study:Week 0 to Week 20; While on study assigned treatment: Week 0 to EOT(Week 8 or earlier); While off study assigned treatment: EOT (Week 8 or earlier) to Week 20 | Recurrence of CMV viremia was defined as plasma CMV DNA concentration \>= lower limit of quantification (LLOQ, i.e. \>=34.5 IU/mL) when assessed by COBAS® 8800/COBAS® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\<LLOQ, i.e. \<34.5 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study. Study Treatment: The first stipulated 8 weeks treatment. Follow up period: period started after completion of stipulated 8 weeks treatment to Week 20. While on study assigned treatment: period over which participants received actual dosing regardless of stipulated 8 weeks completion (Week 8 or earlier). While off study assigned treatment: period after study treatment, regardless of stipulated 8 weeks completion (Week 8 or earlier up to Week 20). |
| Secondary | Percentage of Participants With Any Mutations in the CMV Genes Conferring Resistance to Maribavir | From first dose of study drug up to Week 20 | Plasma samples were obtained and tested to identify mutations in the viral UL97 and UL54 genes confer resistance to maribavir. Percentage of participants with any mutations in the CMV genes conferring resistance to maribavir was reported. |
| Secondary | Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance at Week 8 to be Less Than (<) 137 IU/mL | At Week 8 | The confirmed CMV viremia clearance at Week 8 was defined as plasma CMV DNA concentrations \<137 IU/mL, in 2 consecutive post-baseline samples separated by at least 5 days, regardless of whether study treatment was discontinued before the end of the stipulated 8 weeks of therapy. |
| Secondary | Minimum Observed Plasma Concentration (Cmin) of Maribavir | At Weeks 1, 4, and 8: Pre-dose | Cmin (pre-dose) of maribavir was assessed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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