Actively Recruiting
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
Led by SymBio Pharmaceuticals · Updated on 2026-04-27
180
Participants Needed
61
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form
- Subject or guardian willing and able to understand and provide written informed consent
- Investigator judges clinical condition justifies treatment with IV BCV or IV CDV for adenovirus infection
- Has adenovirus viremia based on any of the following: AdV DNA 2,000 IU/mL or higher; or two consecutive rising AdV DNA results of 1,000 IU/mL or higher at screening; or AdV DNA of 1,000 IU/mL or higher plus one of lymphocyte count less than 180/mm3, received T cell depletion, cord blood or haploidentical transplant, prior alemtuzumab, or anti-thymocyte globulin
You will not qualify if you...
- Subject received an allo-HCT with a matched sibling donor
- Subject received more than 5 mg/kg of cidofovir within 21 days prior to first dose of study drug
- Subject allergic or hypersensitive to IV BCV, IV CDV, or any components
- Subject received anti-adenovirus cell-based therapy within 3 weeks prior to first study drug dose or any anti-adenovirus vaccine at any time
- Subject participated in another investigational study within 30 days or within 5.5 half-lives of the investigational product prior to informed consent, or currently in another interventional treatment trial or using an investigational device at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 61 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Not Yet Recruiting
3
University of California Davis
Sacramento, California, United States, 95616
Not Yet Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Not Yet Recruiting
5
Children's Hospital Colorado-Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
Not Yet Recruiting
6
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Children's Healthcare of Atlanta/Emory
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
8
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
9
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
10
Dana-Farber Cancer Institute-Brighman and Women's
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
11
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, United States, 02139
Not Yet Recruiting
12
Helen Devos Children's Hospital / Michigan State University
Grand Rapids, Michigan, United States, 49503
Not Yet Recruiting
13
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
14
St Louis Children's Hospital - Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
15
University of Nebraska
Omaha, Nebraska, United States, 68182
Not Yet Recruiting
16
Joseph M Sanzari Children's Hospital
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
17
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
18
Weill Cornell Medicine
New York, New York, United States, 10065
Not Yet Recruiting
19
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
20
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
21
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
22
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
23
University of Pittsburgh Medical Center Children's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
24
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
25
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
26
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
27
St. Anna Kinderspital- Childrens Hospital
Vienna, Austria
Not Yet Recruiting
28
Leuven, University Hospital Gasthuisberg
Leuven, Belgium
Not Yet Recruiting
29
Alberta Children's Hospital University of Calgary
Calgary, Canada
Not Yet Recruiting
30
CHU Sainte Justine Hospital
Montreal, Canada
Actively Recruiting
31
The Hospital for Sick Children
Toronto, Canada
Not Yet Recruiting
32
Hôpital Saint-Louis
Paris, France
Not Yet Recruiting
33
Necker Hospital
Paris, France
Not Yet Recruiting
34
Robert-Debré Hospital, APHP Nord Université de Paris Cité.
Paris, France
Not Yet Recruiting
35
Charité University Hospital
Berlin, Germany
Not Yet Recruiting
36
Essen University Hospital
Essen, Germany
Not Yet Recruiting
37
University Hospital Frankfurt, am Main
Frankfurt, Germany
Not Yet Recruiting
38
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, Germany
Not Yet Recruiting
39
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
40
University Children's Hospital
Münster, Germany
Not Yet Recruiting
41
Kinderheilkunde I | Universitätsklinikum Tübingen
Tübingen, Germany
Not Yet Recruiting
42
Istituto Giannina Gaslini
Genova, Italy
Not Yet Recruiting
43
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
44
Perugia Hospital
Perugia, Italy
Not Yet Recruiting
45
Ospedale Pediatrico Bambino Gesu'
Rome, Italy
Not Yet Recruiting
46
IRCCS San Raffaele Hospital
San Raffaele, Italy
Not Yet Recruiting
47
Leiden Unviversity Medical Center
Leiden, Netherlands
Not Yet Recruiting
48
Princess Maxima Center & UMC Utrecht
Utrecht, Netherlands
Not Yet Recruiting
49
Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
Porto, Portugal
Not Yet Recruiting
50
Vall d'Hebron University Hospital
Barcelona, Spain
Not Yet Recruiting
51
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
52
Clinica Universidad de Navarra
Pamplona, Spain
Not Yet Recruiting
53
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
54
Birmingham Women's and Children's Hospital
Birmingham, United Kingdom
Not Yet Recruiting
55
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Not Yet Recruiting
56
Great Ormond Street Hospital for Children
London, United Kingdom
Not Yet Recruiting
57
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
58
Royal Manchester Children's Hospital
Manchester, United Kingdom
Not Yet Recruiting
59
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom
Not Yet Recruiting
60
Sheffield Children's Hospital
Sheffield, United Kingdom
Not Yet Recruiting
61
Royal Marsden Hospital
Sutton, United Kingdom
Not Yet Recruiting
Research Team
R
Rochelle Maher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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