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Efficacy and safety study of intravenous brincidofovir compared to intravenous cidofovir for the treatment of adenovirus infection in children and adults after stem cell transplant
EU CTIS ID: 2025-521903-28-00
What this study is testing
To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Subject is critically ill, for example with sepsis on high dose vasopressors and mechanical ventilation.
- Subject is unable to comply with protocol visits and procedures.
- Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
- Subject is critically ill, for example with sepsis on high dose vasopressors and mechanical ventilation.
- Subject is unable to comply with protocol visits and procedures.
- 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 W1D1.
- 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) leading to hemodynamic instability or radiologic or laboratory evidence attributable to worsening disease.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
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, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. 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 EU CTIS; the study team decides eligibility.