Phase III study of maribavir for CMV paediatric transplant patients
Research type
Research Study
Full title
A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)
IRAS ID
1005419
Contact name
Robert Bradley
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2021-004279-15
Clinicaltrials.gov Identifier
Research summary
Cytomegalovirus (CMV) is a common virus that infects many people, at some time in their life, but they do not know that they have it. In patients with certain conditions, such as those with a transplant or weak immune system, a system that protects person from disease, CMV can become active. When CMV is active, it can be found in the blood. CMV infection can lead to disease involving different organs. Even with the use of medicines to prevent CMV, a CMV infection or disease can still occur.
Although CMV infection causes significant morbidity and mortality in children with hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), treatment options for CMV are limited. There are currently no approved agents for the treatment of CMV infection in paediatric patients <12 years of age.
Maribavir is a new investigational drug that is being tested for the treatment of CMV infection and is approved by the US Food and Drug Administration (FDA) for treating adults and paediatric patients (12 years of age and older) with post-transplant CMV infection that does not respond to available antiviral treatment for CMV.
The purpose of this study is to help determine the following: To understand how patients body processes the study medication (this is called pharmacokinetics or PK) and to identify the best dose for the treatment of CMV infection in children and adolescents. Also, to see how safe the study medication is and if there are unwanted effects on patients health.
This is a multicentre study with about 80 child and adolescent participants taking part at approximately 50 sites in North America, South America, Europe, and Asia Pacific.
Participants will have assessments including physical exam, vital signs, blood tests, weight check and questionnaires.
The study is sponsored by Takeda Development Center Americas, Inc. (TDC Americas)REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0252
Date of REC Opinion
10 May 2023
REC opinion
Further Information Favourable Opinion