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NCT07387367 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
A Phase 3 study of Adenovirus Infections, sponsored by SymBio Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT07387367 is a Phase 3 study of Adenovirus Infections that is actively recruiting participants, run by SymBio Pharmaceuticals. The registered enrollment target is 180 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT07387367, a Phase 3 study of Adenovirus Infections, is actively recruiting participants, sponsored by SymBio Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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.
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.
NCT07387367 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Illinois, Massachusetts.
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.
What interventions are being tested in trial NCT07387367?
The interventions under investigation include: cidofovir (DRUG), Brincidofovir (DRUG).
Who is sponsoring clinical trial NCT07387367?
This trial is sponsored by SymBio Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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