2025-521903-28-00招募中3 期
A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (allo HCT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- Proportion of subjects with AdV virological success
研究概览
简要总结
To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female, post-allo-HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
- •Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.
- •In the investigator’s judgement, the subject’s clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.
- •Has adenoviremia
- •Men and women of childbearing potential (WOCBP) must be willing to use acceptable method(s) of contraception during the study and for at least 6 months after the last dose of IV BCV or at least 6 months after the last dose of IV CDV.
- •Women of childbearing potential (WOCBP) must agree to use two (2) acceptable forms of contraception (one of which must be a barrier method) during heterosexual intercourse. Males capable of fathering a child must agree to use acceptable method(s) of contraception during heterosexual intercourse.
- •Subject is non-pregnant, and either not breast feeding or willing to discontinue breast feeding prior to randomization.
排除标准
- •Subject received an allo-HCT with a matched sibling donor
- •Subject has any other disease, or laboratory abnormality, or clinical finding that, in the judgment of the investigator, would put the subject at unacceptable risk for participation or interfere with study assessments or data quality.
- •Subject is expected to die from a non-adenovirus cause within 30 days from the date of ICF such as a baseline APACHE II score >
- •Subject is unable to comply with protocol visits and procedures
- •Subject is critically ill, for example with sepsis on high dose vasopressors and mechanical ventilation.
- •Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
- •Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
- •Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
- •Subject has participated in any other investigational study within 30 days (or within 5.5 half-lives of the investigational product, whichever is longer) before signing the informed consent form (ICF), is currently participating in another interventional treatment trial with an investigational agent or is using an investigational device at the time of Screening.
- •Subject has NIH Stage 3 or higher acute GVHD of the gut within 7 days prior to W1D
- •Subject has NIH Stage 2 or higher acute GVHD of the liver within 7 days prior to W1D1 (i.e., bilirubin>3 mg/dL [International System, SI: >51 μmol/L]).
- •Subject has exclusionary hepatic parameters within 7 days prior to W1D1: • Total bilirubin >3 mg/dL (SI: >51 μmol/L) except for subjects with Gilbert’s Disease, • Prothrombin time-international normalized ratio (PT INR) >2x ULN, unless attributed to AdV. • ALT or AST >5x upper limit of normal (ULN), except if it is judged by the PI to be due to the AdV infection. Note: Subjects with elevated serum transaminases >5x ULN (CTCAE Grade 3 or higher) due to AdV will be required to demonstrate improvement and must stop study drug if the elevated values have not improved by W3D1: either at least one CTCAE grade or clinical improvement based on the physician’s assessment.
- •Subject has uncontrolled viral (other than AdV), bacterial, or fungal infection(s).
结局指标
主要结局
Proportion of subjects with AdV virological success
Proportion of subjects with AdV virological success
次要结局
- Proportion of subjects with overall success
- Proportion of subjects with clinical success
- Proportion of subjects with AdV virological success
- Correlation of virologic success and clinical response
- AdV-free survival
- Time to AdV virological success
- Rate of AdV recurrence
- Length of hospitalization and length of ICU stay
- Desirability Of Outcome Ranking (DOOR) Analysis for benefit-risk estimation
- All-cause mortality
- Adenovirus attributed mortality, as adjudicated by the EAC
- Primary malignancy relapse-free survival
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究者
Chief Medical Officer
Scientific
Symbio Pharmaceuticals Ltd.
研究点 (5)
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