RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: SymBio Pharmaceuticals • ClinicalTrials.gov ID: NCT07387367

Registry updated: 2026-10-19

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Description

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.

Interventions

cidofovir (Drug)
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 (Drug)
Intravenous

Eligibility criteria

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.

Conditions

Adenovirus Infections

Locations

Phoenix Children's Hospital — Phoenix, Arizona, United States
City of Hope — Duarte, California, United States
Stanford Medicine Children's Health — Palo Alto, 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
Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Ann and Robert H Lurie Children's Hospital — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Riley Children's Health (Indiana University) — Indianapolis, Indiana, 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
Columbia University Irving Medical Center — New York, 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 Pittsburgh Medical Center Children's Hospital — Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital — Memphis, Tennessee, United States
UT Southwestern Medical Center — Dallas, Texas, United States
Seattle Children's Hospital — Seattle, Washington, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States
Medical College of Wisconsin / Children's Wisconsin — Milwaukee, Wisconsin, United States
St. Anna Kinderspital- Childrens Hospital — Vienna, Austria
Leuven, University Hospital Gasthuisberg — Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Liège — Liège, Belgium
University Health Network- Princess Margaret Cancer Centre — Toronto, Ontario Province, Canada
Hopital Maisonneuve-Rosemont - CIUSSS de l Est de L Ile de Montreal — Montreal, Quebec Province, Canada
Montreal Children's Hospital - McGill University Health Centre — Montreal, Quebec Province, Canada
Alberta Children's Hospital University of Calgary — Calgary, Canada
CHU Sainte Justine Hospital — Montreal, Canada
The Hospital for Sick Children — Toronto, Canada
Rigshospitalet — Copenhagen, Denmark
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin — Bordeaux, France
Hopital Jeanne de Flandre — Lille, France
Centre Hospitalier Régional Universitaire de Nancy (CHRU) - Hopitaux de Brabois - Hôpital d'enfants — Nancy, France
Centre Hospitalier Universitaire (CHU) de Nantes - Hôpital Mère-Enfants — Nantes, France
Hôpital Saint-Louis — Paris, France
Necker Hospital — Paris, France
Robert-Debré Hospital, APHP Nord Université de Paris Cité. — Paris, France
Centre Hospitalier Universitaire (CHU) de Rennes - Hôpital Sud — Rennes, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre — Strasbourg, France
Charité University Hospital — Berlin, Germany
Essen University Hospital — Essen, Germany
University Hospital Frankfurt, am Main — Frankfurt, Germany
University Medical Center Freiburg — Freiburg im Breisgau, 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 de Lisboa (IPO Lisboa) Francisco Gentil, EPE — Lisbon, Portugal
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
Hospital Universitario de Salamanca — Salamanca, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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