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New treatment option for Cytomegalovirus (CMV)
Official title A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
ClinicalTrials.gov ID: NCT06439342
What this study is testing
What is Maribavir?
Maribavir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cytomegalovirus (cmv).
Also referred to as TAK-620.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and...
- The participant/participant's legally representative has provided informed consent (that is, in writing, documented via a signed and dated informed...
- 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.
You likely can't join if
- The participant has CMV disease with central nervous system (CNS involvement) (eg, CMV encephalitis) or ophthalmic involvement (eg, CMV retinitis) as...
- 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...
- The participant has a known hypersensitivity to maribavir or to any excipients.
- The participant has severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of...
- The participant has any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- The participant must be able to swallow tablets, or receive tablets crushed and/or dispersed in water via a nasogastric or orogastric tube.
What rules you out
- 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.
- The participant has severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of investigational product or a GI absorption abnormality that would preclude...
- The participant has any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the...
- The participant is receiving valganciclovir, ganciclovir, cidofovir, foscarnet, letermovir, leflunomide, or artesunate when investigational product is initiated, or anticipated to require one of these agents during the...
- The participant requires mechanical ventilation or vasopressors for hemodynamic support at the time of baseline.
- The participant has previously received maribavir.
- The participant has previously completed, discontinued, or have been withdrawn from this study.
- The participant has received any investigational agent with known anti-CMV activity within 30 days before initiation of investigational product or CMV vaccine at any time.
- The participant has received any investigational agent or device within 30 days before initiation of investigational product.
- The participant has serum aspartate aminotransferase (AST) \>5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) \>5 times ULN at screening, or total bilirubin \>=3.0 × ULN at...
- The participant has known (previously documented) positive results for human immunodeficiency virus (HIV). Participant must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be...
- The participant has active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which...
- The participant is undergoing treatment for acute or chronic hepatitis C and hepatitis B.
- The participant is pregnant or expecting to conceive or nursing/breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Beijing, North China, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Suzhou, Jiangsu, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.