New drug could beat virus threat in transplant patients

NCT ID NCT07387367

Disease control Sponsor: SymBio Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This study tests a new drug, brincidofovir, against the current treatment cidofovir for adenovirus infection in children and adults who have had a stem cell transplant. About 180 participants will receive one of the two drugs intravenously until the virus is cleared or up to 12 weeks. The goal is to see which drug works better and is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Brincidofovir (IV) and cidofovir (IV)
What this could lead to: If brincidofovir works better or is safer than cidofovir, it could become a preferred treatment for adenovirus infections in stem cell transplant patients.
What could go wrong: This is an early Phase 3 trial with only 180 participants, so results may not apply to all patients. Both drugs can cause kidney or liver side effects, and brincidofovir may not prove superior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adenoviridae infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenovirus infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

81 sites in 13 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Alberta Children's Hospital University of Calgary
NOT_YET_RECRUITING

Calgary, Canada
Ann and Robert H Lurie Children's Hospital
RECRUITING

Chicago, Illinois, 60611, United States
Birmingham Women's and Children's Hospital
NOT_YET_RECRUITING

Birmingham, United Kingdom
CHU Sainte Justine Hospital
RECRUITING

Montreal, Canada
Centre Hospitalier Régional Universitaire de Nancy (CHRU) - Hopitaux de Brabois - Hôpital d'enfants
NOT_YET_RECRUITING

Nancy, France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin
NOT_YET_RECRUITING

Bordeaux, France
Centre Hospitalier Universitaire (CHU) de Liège
NOT_YET_RECRUITING

Liège, Belgium
Centre Hospitalier Universitaire (CHU) de Nantes - Hôpital Mère-Enfants
NOT_YET_RECRUITING

Nantes, France
Centre Hospitalier Universitaire (CHU) de Rennes - Hôpital Sud
NOT_YET_RECRUITING

Rennes, France
Charité University Hospital
NOT_YET_RECRUITING

Berlin, Germany
Children's Healthcare of Atlanta
RECRUITING

Atlanta, Georgia, 30329, United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Children's National Hospital
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital
RECRUITING

Cincinnati, Ohio, 45229, United States
City of Hope
RECRUITING

Duarte, California, 91010, United States
Clinica Universidad de Navarra
RECRUITING

Pamplona, Spain
Cohen Children's Medical Center
RECRUITING

New Hyde Park, New York, 11042, United States
Columbia University Irving Medical Center
NOT_YET_RECRUITING

New York, New York, 10032, United States
Dana-Farber Cancer Institute-Brighman and Women's
RECRUITING

Boston, Massachusetts, 02115, United States
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
RECRUITING

Boston, Massachusetts, 02139, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Essen University Hospital
RECRUITING

Essen, Germany
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING

Pavia, Italy
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING

Seattle, Washington, 98109, United States
Great Ormond Street Hospital for Children
NOT_YET_RECRUITING

London, United Kingdom
Helen Devos Children's Hospital / Michigan State University
NOT_YET_RECRUITING

Grand Rapids, Michigan, 49503, United States
Hopital Jeanne de Flandre
NOT_YET_RECRUITING

Lille, France
Hopital Maisonneuve-Rosemont - CIUSSS de l Est de L Ile de Montreal
NOT_YET_RECRUITING

Montreal, Quebec Province, Canada
Hospital Universitario La Paz
RECRUITING

Madrid, Spain
Hospital Universitario de Salamanca
NOT_YET_RECRUITING

Salamanca, Spain
Hôpital Saint-Louis
NOT_YET_RECRUITING

Paris, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
NOT_YET_RECRUITING

Strasbourg, France
IRCCS San Raffaele Hospital
NOT_YET_RECRUITING

San Raffaele, Italy
Instituto Português de Oncologia de Lisboa (IPO Lisboa) Francisco Gentil, EPE
NOT_YET_RECRUITING

Lisbon, Portugal
Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
NOT_YET_RECRUITING

Porto, Portugal
Istituto Giannina Gaslini
RECRUITING

Genova, Italy
Johns Hopkins All Children's Hospital
NOT_YET_RECRUITING

St. Petersburg, Florida, 33701, United States
Joseph M Sanzari Children's Hospital
RECRUITING

Hackensack, New Jersey, 07601, United States
Karolinska University Hospital
NOT_YET_RECRUITING

Stockholm, Sweden
Kinderheilkunde I | Universitätsklinikum Tübingen
NOT_YET_RECRUITING

Tübingen, Germany
Leeds Teaching Hospitals NHS Trust
RECRUITING

Leeds, United Kingdom
Leiden Unviversity Medical Center
NOT_YET_RECRUITING

Leiden, Netherlands
Leuven, University Hospital Gasthuisberg
NOT_YET_RECRUITING

Leuven, Belgium
Medical College of Wisconsin / Children's Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medizinische Hochschule Hannover
NOT_YET_RECRUITING

Hanover, Germany
Montreal Children's Hospital - McGill University Health Centre
NOT_YET_RECRUITING

Montreal, Quebec Province, Canada
Nationwide Children's Hospital
NOT_YET_RECRUITING

Columbus, Ohio, 43205, United States
Necker Hospital
NOT_YET_RECRUITING

Paris, France
Ospedale Pediatrico Bambino Gesu'
RECRUITING

Rome, Italy
Perugia Hospital
RECRUITING

Perugia, Italy
Phoenix Children's Hospital
RECRUITING

Phoenix, Arizona, 85016, United States
Princess Maxima Center & UMC Utrecht
NOT_YET_RECRUITING

Utrecht, Netherlands
Rady Children's Hospital
NOT_YET_RECRUITING

San Diego, California, 92123, United States
Rigshospitalet
NOT_YET_RECRUITING

Copenhagen, Denmark
Riley Children's Health (Indiana University)
RECRUITING

Indianapolis, Indiana, 46202, United States
Robert-Debré Hospital, APHP Nord Université de Paris Cité.
RECRUITING

Paris, France
Royal Manchester Children's Hospital
RECRUITING

Manchester, United Kingdom
Royal Marsden Hospital
NOT_YET_RECRUITING

Sutton, United Kingdom
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States
Sheffield Children's Hospital
RECRUITING

Sheffield, United Kingdom
St Louis Children's Hospital - Barnes Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States
St. Anna Kinderspital- Childrens Hospital
NOT_YET_RECRUITING

Vienna, Austria
St. Jude Children's Research Hospital
RECRUITING

Memphis, Tennessee, 38105, United States
Stanford Medicine Children's Health
NOT_YET_RECRUITING

Palo Alto, California, 94304, United States
The Hospital for Sick Children
RECRUITING

Toronto, Canada
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
RECRUITING

Newcastle upon Tyne, United Kingdom
UT Southwestern Medical Center
NOT_YET_RECRUITING

Dallas, Texas, 75390, United States
University Children's Hospital
NOT_YET_RECRUITING

Münster, Germany
University College London Hospitals NHS Foundation Trust
RECRUITING

London, United Kingdom
University Health Network- Princess Margaret Cancer Centre
NOT_YET_RECRUITING

Toronto, Ontario Province, Canada
University Hospital Frankfurt, am Main
RECRUITING

Frankfurt, Germany
University Medical Center Freiburg
NOT_YET_RECRUITING

Freiburg im Breisgau, Germany
University Medical Center Hamburg-Eppendorf (UKE)
NOT_YET_RECRUITING

Hamburg, Germany
University of California Davis
RECRUITING

Sacramento, California, 95616, United States
University of Chicago
NOT_YET_RECRUITING

Chicago, Illinois, 60637, United States
University of Minnesota
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Nebraska
RECRUITING

Omaha, Nebraska, 68182, United States
University of Pittsburgh Medical Center Children's Hospital
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Vall d'Hebron University Hospital
NOT_YET_RECRUITING

Barcelona, Spain
Weill Cornell Medicine
RECRUITING

New York, New York, 10065, United States

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