Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
Sponsor: SymBio Pharmaceuticals
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.
Official title: A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir Versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
Key Details
Gender
All
Age Range
2 Months - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-02-15
Completion Date
2028-06-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
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
Locations (61)
Phoenix Children's Hospital
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
University of California Davis
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta/Emory
Atlanta, Georgia, United States
Ann and Robert H Lure Children's Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute-Brighman and Women's
Boston, Massachusetts, United States
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, United States
Helen Devos Children's Hospital / Michigan State University
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St Louis Children's Hospital - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Joseph M Sanzari Children's Hospital
Hackensack, New Jersey, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
Weill Cornell Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburg Medical Center Children's Hospital
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Seattle Children's Hospital
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
St. Anna Kinderspital- Childrens Hospital
Vienna, Austria
Leuven, University Hospital Gasthuisberg
Leuven, Belgium
Alberta Children's Hospital University of Calgary
Calgary, Canada
CHU Sainte Justine Hospital
Montreal, Canada
The Hospital for Sick Children
Toronto, Canada
Hôpital Saint-Louis
Paris, France
Necker Hospital
Paris, France
Robert-Debré Hospital, APHP Nord Université de Paris Cité.
Paris, France
Charité University Hospital
Berlin, Germany
Essen University Hospital
Essen, Germany
University Hospital Frankfurt, am Main
Frankfurt, Germany
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
University Children's Hospital
Münster, Germany
Kinderheilkunde I | Universitätsklinikum Tübingen
Tübingen, Germany
Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Perugia Hospital
Perugia, Italy
Ospedale Pediatrico Bambino Gesu'
Rome, Italy
IRCCS San Raffaele Hospital
San Raffaele, Italy
Leiden Unviversity Medical Center
Leiden, Netherlands
Princess Maxima Center & UMC Utrecht
Utrecht, Netherlands
Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
Porto, Portugal
Vall d'Hebron University Hospital
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Karolinska University Hospital
Stockholm, Sweden
Birmingham Women's and Children's Hospital
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom