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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)

Status: Recruiting
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Healthy Volunteers: f
View:

• Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.

• Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.

• In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.

• 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)

Locations
United States
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
City of Hope
NOT_YET_RECRUITING
Duarte
University of California Davis
NOT_YET_RECRUITING
Sacramento
Rady Children's Hospital
NOT_YET_RECRUITING
San Diego
Colorado
Children's Hospital Colorado-Center for Cancer and Blood Disorders
NOT_YET_RECRUITING
Aurora
Washington, D.c.
Children's National Hospital
NOT_YET_RECRUITING
Washington D.c.
Georgia
Children's Healthcare of Atlanta/Emory
NOT_YET_RECRUITING
Atlanta
Illinois
Ann and Robert H Lure Children's Hospital
NOT_YET_RECRUITING
Chicago
University of Chicago
NOT_YET_RECRUITING
Chicago
Massachusetts
Dana-Farber Cancer Institute-Brighman and Women's
NOT_YET_RECRUITING
Boston
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
NOT_YET_RECRUITING
Boston
Michigan
Helen Devos Children's Hospital / Michigan State University
NOT_YET_RECRUITING
Grand Rapids
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
Missouri
St Louis Children's Hospital - Barnes Jewish Hospital
RECRUITING
St Louis
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
Nebraska
University of Nebraska
NOT_YET_RECRUITING
Omaha
New Jersey
Joseph M Sanzari Children's Hospital
NOT_YET_RECRUITING
Hackensack
New York
Cohen Children's Medical Center
NOT_YET_RECRUITING
New Hyde Park
Weill Cornell Medicine
NOT_YET_RECRUITING
New York
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
University of Pittsburg Medical Center Children's Hospital
NOT_YET_RECRUITING
Pittsburgh
Tennessee
St. Jude Children's Research Hospital
NOT_YET_RECRUITING
Memphis
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
Seattle Children's Hospital
NOT_YET_RECRUITING
Seattle
Other Locations
Austria
St. Anna Kinderspital- Childrens Hospital
NOT_YET_RECRUITING
Vienna
Belgium
Leuven, University Hospital Gasthuisberg
NOT_YET_RECRUITING
Leuven
Canada
Alberta Children's Hospital University of Calgary
NOT_YET_RECRUITING
Calgary
CHU Sainte Justine Hospital
NOT_YET_RECRUITING
Montreal
The Hospital for Sick Children
NOT_YET_RECRUITING
Toronto
France
Hôpital Saint-Louis
NOT_YET_RECRUITING
Paris
Necker Hospital
NOT_YET_RECRUITING
Paris
Robert-Debré Hospital, APHP Nord Université de Paris Cité.
NOT_YET_RECRUITING
Paris
Germany
Charité University Hospital
NOT_YET_RECRUITING
Berlin
Essen University Hospital
NOT_YET_RECRUITING
Essen
University Hospital Frankfurt, am Main
NOT_YET_RECRUITING
Frankfurt
University Medical Center Hamburg-Eppendorf (UKE)
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
University Children's Hospital
NOT_YET_RECRUITING
Münster
Kinderheilkunde I | Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Italy
Istituto Giannina Gaslini
NOT_YET_RECRUITING
Genova
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Perugia Hospital
NOT_YET_RECRUITING
Perugia
Ospedale Pediatrico Bambino Gesu'
NOT_YET_RECRUITING
Rome
IRCCS San Raffaele Hospital
NOT_YET_RECRUITING
San Raffaele
Netherlands
Leiden Unviversity Medical Center
NOT_YET_RECRUITING
Leiden
Princess Maxima Center & UMC Utrecht
NOT_YET_RECRUITING
Utrecht
Portugal
Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
NOT_YET_RECRUITING
Porto
Spain
Vall d'Hebron University Hospital
NOT_YET_RECRUITING
Barcelona
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Clinica Universidad de Navarra
NOT_YET_RECRUITING
Pamplona
Sweden
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
United Kingdom
Birmingham Women's and Children's Hospital
NOT_YET_RECRUITING
Birmingham
Leeds Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Leeds
Great Ormond Street Hospital for Children
NOT_YET_RECRUITING
London
University College London Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
London
Royal Manchester Children's Hospital
NOT_YET_RECRUITING
Manchester
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Sheffield Children's Hospital
NOT_YET_RECRUITING
Sheffield
Royal Marsden Hospital
NOT_YET_RECRUITING
Sutton
Contact Information
Primary
Rochelle Maher
MedInfo@symbiopharma.com
+1-917-656-6951
Time Frame
Start Date: 2026-02-15
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 180
Treatments
Experimental: IV BCV
Active_comparator: IV CDV
Related Therapeutic Areas
Sponsors
Leads: SymBio Pharmaceuticals

This content was sourced from clinicaltrials.gov