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A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
NCT07387367 · View on ClinicalTrials.gov ↗
Study Summary
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. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.
Conditions Studied
Interventions
- DRUG cidofovir
- DRUG Brincidofovir
Study Locations (20)
California
- City of Hope — Duarte
- University of California Davis — Sacramento
- Rady Children's Hospital — San Diego
Illinois
- Ann and Robert H Lure Children's Hospital — Chicago
- University of Chicago — Chicago
Massachusetts
- Dana-Farber Cancer Institute-Brighman and Women's — Boston
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center — Boston
New York
- Cohen Children's Medical Center — New Hyde Park
- Weill Cornell Medicine — New York
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado-Center for Cancer and Blood Disorders — Aurora
District of Columbia
- Children's National Hospital — Washington D.C.
Georgia
- Children's Healthcare of Atlanta/Emory — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-02-15 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07387367
The ClinicalTrials.gov registry entry for NCT07387367 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SymBio Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Adenovirus Infections appearing as the primary indexed condition, and to 2 interventions — of which cidofovir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07387367 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07387367 about?
NCT07387367 is a clinical study titled "A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT". 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 w...
What is the current status of trial NCT07387367?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2026-02-15. Estimated completion is 2028-06-30.
What conditions does trial NCT07387367 study?
This clinical trial studies the following conditions: Adenovirus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07387367?
The interventions under investigation include: cidofovir (DRUG), Brincidofovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07387367?
This trial is sponsored by SymBio Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07387367 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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