EUCTR2021-004279-15-FR进行中（未招募）1 期
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) - Protego
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Parent/both parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study-related procedures. During the coronavirus disease (COVID-19) public health emergency, informed consent from a potential or current trial subject may, if permitted by local laws and regulations, be obtained via electronic informed consent capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site.Subjects must also;
- •2.Be a male or female child or adolescent <18 years of age at the time of consent; for subjects in Cohort3 only, must have a minimum gestational age of at least 38 weeks and minimum weight of 5kg. 3.Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
- •4.Have a documented CMV infection, with a CMV DNA screening value of =1365IU/mL in whole blood or =455 IU/mL in plasma in 2 consecutive assessments within 14 days of first dose of study drug, separated by at least 1day, by qPCR or comparable quantitative CMV DNA results.
- •5.Have all the following results as part of screening laboratory assessments:a.Absolute neutrophil count =500/mm3(0.5×109/L)b.Platelet count =15,000/mm3(15×109/L)c.Hemoglobin =7 g/dL.
- •6.Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz equation)=30mL/min/1.73 m2.
- •7.Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-hCG(ß-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating females who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the study treatment administration period and for 90days after the last dose of study treatment.
- •8.Be able to swallow awholetablet until a liquid formulation becomes available for the study.
- •9.Have life expectancy of =8 weeks.
- •10.Be willing and have an understanding and ability to fully comply with the study procedures and restrictions defined in the protocol. For younger children, the parent/both parents or LAR must meet this criterion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must not:
- •1.Have CMV tissue invasive disease involving the central nervous system or retina as assessed by the investigator at the time of screening.
- •2.Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
- •3.Have 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.
- •4.Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or anticipated to require one of these agents during the 8-week treatment period.
- •5.Have a known hypersensitivity to maribavir or to any excipients.
- •6.Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI absorption abnormality that would preclude administration of oral medication.
- •7.Require mechanicalventilation or vasopressors for hemodynamic support at baseline(Visit2/Day0/Week0).
- •8.Be pregnant (or expecting to conceive) or nursing.
- •9.Have previously completed, discontinued, or have been withdrawn from this study.
- •10.Have received an investigational agentor devicewithin 30 days before initiation of study treatment (includes any investigational agent with known anti-CMV activity, and CMV-specific T-cells). Previously approved agents under investigation for additional indications are not exclusionary.
- •11.Have previously received maribavir or CMV vaccine at any time.
- •12.Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of theassigned study treatment, or compromise the safety or well-being of the subject.
- •13.Have severe liver disease (Child-Pugh score of =10).
- •14.Have serum aspartate aminotransferase >5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase >5 times ULN at screening, or total bilirubin =3.0 times ULN at screening (except for documented Gilbert’s syndrome), as analyzed by local laboratory.
- •15.Have known (previously documented) positive results for human immunodeficiency virus (HIV). Subjects must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
- •16.Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Subjects who experience relapse or progression of their underlying malignancy (for which HSCT or SOT was performed), as determined by the investigator, are not to be enrolled.
- •17.Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
研究者
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