An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• The participant must be a recipient of hematopoietic stem cell or solid organ transplant.

• The participant must have a documented CMV infection in whole blood or plasma, with a screening value of \>=1,365 International unit per milliliter IU/mL in whole blood or \>=455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to receiving the investigational product with second sample obtained within 5 days prior to receiving the investigational product. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.

• The participant must have a current CMV infection that is refractory to the most recently administered of the 4 anti-CMV treatment agent(s) eg, intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir. Refractory is defined as documented failure to achieve greater than (\>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with the above 4 agents.

• Participants who have documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, cidofovir, or foscarnet must also meet the definition of refractory CMV infection.

• Have all the following results as part of screening laboratory assessments:

‣ Absolute neutrophil count \>=1000 per cubic millimeter (/mm\^3) (1\*10\^9 per liter \[/L\]).

⁃ Platelet count \>= 25,000/mm\^3 (25\*10\^9/L)

⁃ Hemoglobin \>= 8 grams per deciliter (g/dL)

⁃ Estimated glomerular filtration rate \>= 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula.

• The participant must have life expectancy of at least 8 weeks.

• The participant has a body weight of at least 35 kilogram (kg).

• The female participant either be of nonchildbearing potential, or if of childbearing potential then have a negative serum human chorionic gonadotropin (hCG) or beta-hCG (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating female participants who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the investigational product administration period and for 90 days after the last dose of investigational product.

• The participant must be able to swallow tablets, or receive tablets crushed and/or dispersed in water via a nasogastric or orogastric tube.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Xinqiao Hospital Army Medical University
RECRUITING
Chongqing
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital(The First Affiliated Hospital of USTC)
RECRUITING
Hefei
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Maribavir
Participants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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