A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
ConditionCytomegalovirus (CMV)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment with maribavir. Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms, the recurrence rate of CMV infection after treatment with maribavir and if the treatment is required again. Researchers will also check for changes (mutations) occurring in the virus which may cause treatment with maribavir to no longer work well or to not work at all (resistance to maribavir).
The participants will be treated with maribavir for 8 weeks.
During the study, participants will visit their study clinic 18 times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
The participant/participant's legally representative has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF]) and any required privacy authorization prior to the initiation of any study procedures.
The participant is aged 18 years or older (ie, greater than or equal to [>=] 18 years) at the time of signing the ICF.
The participant must be of Chinese descent, defined as born in China and having Chinese parents and Chinese maternal and paternal grandparents.
Disqualifiers
The participant has CMV disease with central nervous system (CNS involvement) (eg, CMV encephalitis) or ophthalmic involvement (eg, CMV retinitis) as assessed by the investigator at the time of screening.
That participant has uncontrolled other type of infection as assessed by the investigator on the date of treatment assignment.
The participant has a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator.
The participant has a known hypersensitivity to maribavir or to any excipients.
Trial design
Design model
Single group
Treatments tested in this trial
Maribavir
DrugMaribavir tablets
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MaribavirExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs)
TEAEs will be defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria. AESIs is defined as any adverse event of special interest.
Time frame
From first dose of study drug up to Week 202
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs will include temperature, arterial blood pressure (systolic and diastolic) and pulse. Any change in vital signs assessments which will be deemed clinically significant by the investigator will be reported.
Time frame
From first dose of study drug up to Week 203
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Clinical laboratory parameters will include chemistry, hematology, and urinalysis. Any clinical laboratory abnormalities which will be deemed clinically significant by the investigator will be recorded.
Time frame
From first dose of study drug up to Week 204
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
12-lead ECG will be evaluated. Any ECG assessments which will be deemed clinically significant by the investigator will be reported.
Time frame
From first dose of study drug up to Week 20Secondary outcomes
1
Percentage of Participants With Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) (CMV Viremia Clearance) at Week 8
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (\<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy.
Time frame
At Week 82
Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Weeks 8, 12, 16, and 20
Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (\<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. This outcome measure will be assessed regardless of whether participants complete the stipulated 8 weeks of study-assigned treatment.
Time frame
At Weeks 8, 12, 16 and 203
Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 (After Completion of 8 Weeks Therapy)
Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration \<LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline.
Time frame
At Week 84
Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control After Completion of 8 weeks Therapy Followed by Maintenance of This Treatment Effect Through Weeks 12, 16 and 20
Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration \<LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. The maintenance of treatment effect will be based on the achievement of CMV viremia clearance and symptom control at Week 8 after completion of 8 weeks therapy, followed by maintenance of this treatment effect through Weeks 12, 16 and 20.
Time frame
At Weeks 12, 16 and 20 Source ClinicalTrials.gov