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Clinical Trials in the USA / NCT07387367
Recruiting Phase 3

A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

NCT07387367 · tracked via the Priya Life Science USA tracker
Sponsor
SymBio Pharmaceuticals
Phase
Phase 3
Started
2026-03-17
Last updated
2026-08-10

Condition(s) studied

Adenovirus Infections

Investigational drug(s) / intervention(s)

cidofovirBrincidofovir

cidofovir: CDV does not have a labeled indication for treating Adenovirus infection. CDV will be administered according to local guidelines and institutional standard of care practice.

Brincidofovir: Intravenous

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.

Eligibility

Sex
ALL
Min age
2 Months
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form. 2. Subject/Guardian willing and able to understand and provide written informed consent to participate in the study. 3. In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection. 4. 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) Exclusion Criteria: 1. Subject received an allo-HCT with a matched sibling donor 2. Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug. 3. Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components. 4. Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time. 5. 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.

Primary outcome measure(s)

Trial sites (81)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona Recruiting
City of Hope Duarte California Recruiting
Stanford Medicine Children's Health Palo Alto California Not Yet Recruiting
University of California Davis Sacramento California Recruiting
Rady Children's Hospital San Diego California Not Yet Recruiting
Children's Hospital Colorado-Center for Cancer and Blood Disorders Aurora Colorado Not Yet Recruiting
Children's National Hospital Washington D.C. District of Columbia Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida Not Yet Recruiting
Children's Healthcare of Atlanta Atlanta Georgia Recruiting
Ann and Robert H Lurie Children's Hospital Chicago Illinois Recruiting
University of Chicago Chicago Illinois Not Yet Recruiting
Riley Children's Health (Indiana University) Indianapolis Indiana Recruiting
Dana-Farber Cancer Institute-Brighman and Women's Boston Massachusetts Recruiting
Dana-Farber/Boston Children's Cancer and Blood Disorders Center Boston Massachusetts Recruiting
Helen Devos Children's Hospital / Michigan State University Grand Rapids Michigan Not Yet Recruiting
University of Minnesota Minneapolis Minnesota Not Yet Recruiting
St Louis Children's Hospital - Barnes Jewish Hospital St Louis Missouri Recruiting
University of Nebraska Omaha Nebraska Recruiting
Joseph M Sanzari Children's Hospital Hackensack New Jersey Recruiting
Cohen Children's Medical Center New Hyde Park New York Recruiting
Columbia University Irving Medical Center New York New York Not Yet Recruiting
Weill Cornell Medicine New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
Cincinnati Children's Hospital Cincinnati Ohio Recruiting
Nationwide Children's Hospital Columbus Ohio Not Yet Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Children's Hospital Pittsburgh Pennsylvania Not Yet Recruiting
St. Jude Children's Research Hospital Memphis Tennessee Recruiting
UT Southwestern Medical Center Dallas Texas Not Yet Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
Fred Hutchinson Cancer Center Seattle Washington Not Yet Recruiting
Medical College of Wisconsin / Children's Wisconsin Milwaukee Wisconsin Recruiting
St. Anna Kinderspital- Childrens Hospital Vienna Austria Not Yet Recruiting
Leuven, University Hospital Gasthuisberg Leuven Belgium Not Yet Recruiting
Centre Hospitalier Universitaire (CHU) de Liège Liège Belgium Not Yet Recruiting
University Health Network- Princess Margaret Cancer Centre Toronto Ontario Province Not Yet Recruiting
Hopital Maisonneuve-Rosemont - CIUSSS de l Est de L Ile de Montreal Montreal Quebec Province Not Yet Recruiting
Montreal Children's Hospital - McGill University Health Centre Montreal Quebec Province Not Yet Recruiting
Alberta Children's Hospital University of Calgary Calgary Canada Not Yet Recruiting
CHU Sainte Justine Hospital Montreal Canada Recruiting

+ 41 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07387367 on ClinicalTrials.gov ↗ ← All trials in the USA