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Compares treatment options for Adenovirus Infections
Official title A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
ClinicalTrials.gov ID: NCT07387367
What this study is testing
What is cidofovir?
cidofovir is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for adenovirus infections.
Also referred to as IV CDV.
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
- This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
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, based on any of:
- AdV viremia DNA ≥10,000 IU/mL, OR
You likely can't join if
- Subject received an allo-HCT with a matched sibling donor
- 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...
See the full eligibility criteria
- 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, based on any of:
- AdV viremia DNA ≥10,000 IU/mL, OR
- Two consecutive and rising AdV viremia DNA results of ≥1,000 IU/mL at screening, OR
- AdV viremia DNA of ≥1,000 IU/mL, AND 1\. Lymphocyte count \<180/mm3, OR 2. Received T cell depletion, cord blood, or haploidentical transplant, OR 3. prior alemtuzumab, OR 4. anti-thymocyte globulin (ATG)
- Subject received an allo-HCT with a matched sibling donor
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
+ 35 more site(s).
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, 2 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Sacramento, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States and 49 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.