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

NCT07387367 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BCV-PA02
• Study Type: interventional
• Target: 180
• Locations: 12 countries
• Sites: 61

Brief 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.

Conditions

Adenovirus Infections

Keywords

Brincidofovir; Cidofovir; Adenovirus; allo-HCT; BCV-PA02; ENOVIA

Outcome Measures

Primary Outcomes (1)

• To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.

  The primary efficacy endpoint is defined as AdV virological success at W5D1. -Proportion of subjects with AdV virological success

  Week (W) 5 Day (D) 1.

Secondary Outcomes (4)

• To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.

  Test Of Cure (Last Dose + 30 days)

• To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.

  Week 1 Day 1 Through End Of Study (Week 24).

• To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.

  Week 5 Day 1, Last Dose + 4 Days, Last Dose + 30 days, Week 12, and Week 24.

• BCV Plasma Concentrations will be collected, measured and reported

  Plasma samples will be collected at Week 1 Day 1, and Week 5 Day 1

Study Arms (2)

IV BCV

EXPERIMENTAL

Drug: Brincidofovir

IV CDV

ACTIVE COMPARATOR

Drug: cidofovir

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.

Also known as: IV CDV

IV CDV

Brincidofovir DRUG

Intravenous

Also known as: SyB V-1901

IV BCV

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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)

You may not qualify if:

• Subject received an allo-HCT with a matched sibling donor
• Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
• Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
• Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
• 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.

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (61)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

NOT YET RECRUITING

University of California Davis

Sacramento, California, 95616, United States

NOT YET RECRUITING

Rady Children's Hospital

San Diego, California, 92123, United States

NOT YET RECRUITING

Children's Hospital Colorado-Center for Cancer and Blood Disorders

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Children's Healthcare of Atlanta/Emory

Atlanta, Georgia, 30329, United States

NOT YET RECRUITING

Ann and Robert H Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute-Brighman and Women's

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Dana-Farber/Boston Children's Cancer and Blood Disorders Center

Boston, Massachusetts, 02139, United States

NOT YET RECRUITING

Helen Devos Children's Hospital / Michigan State University

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

NOT YET RECRUITING

St Louis Children's Hospital - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska

Omaha, Nebraska, 68182, United States

NOT YET RECRUITING

Joseph M Sanzari Children's Hospital

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, 11042, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Pittsburgh Medical Center Children's Hospital

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

St. Anna Kinderspital- Childrens Hospital

Vienna, Austria

NOT YET RECRUITING

Leuven, University Hospital Gasthuisberg

Leuven, Belgium

NOT YET RECRUITING

Alberta Children's Hospital University of Calgary

Calgary, Canada

NOT YET RECRUITING

CHU Sainte Justine Hospital

Montreal, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Canada

NOT YET RECRUITING

Hôpital Saint-Louis

Paris, France

NOT YET RECRUITING

Necker Hospital

Paris, France

NOT YET RECRUITING

Robert-Debré Hospital, APHP Nord Université de Paris Cité.

Paris, France

NOT YET RECRUITING

Charité University Hospital

Berlin, Germany

NOT YET RECRUITING

Essen University Hospital

Essen, Germany

NOT YET RECRUITING

University Hospital Frankfurt, am Main

Frankfurt, Germany

NOT YET RECRUITING

University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

NOT YET RECRUITING

University Children's Hospital

Münster, Germany

NOT YET RECRUITING

Kinderheilkunde I | Universitätsklinikum Tübingen

Tübingen, Germany

NOT YET RECRUITING

Istituto Giannina Gaslini

Genova, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

Perugia Hospital

Perugia, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambino Gesu'

Rome, Italy

NOT YET RECRUITING

IRCCS San Raffaele Hospital

San Raffaele, Italy

NOT YET RECRUITING

Leiden Unviversity Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Princess Maxima Center & UMC Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

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

Porto, Portugal

NOT YET RECRUITING

Vall d'Hebron University Hospital

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

Birmingham Women's and Children's Hospital

Birmingham, United Kingdom

NOT YET RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

NOT YET RECRUITING

Great Ormond Street Hospital for Children

London, United Kingdom

NOT YET RECRUITING

University College London Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Royal Manchester Children's Hospital

Manchester, United Kingdom

NOT YET RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, United Kingdom

NOT YET RECRUITING

Sheffield Children's Hospital

Sheffield, United Kingdom

NOT YET RECRUITING

Royal Marsden Hospital

Sutton, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Adenoviridae Infections

Interventions

Cidofovir; brincidofovir

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nkechi Azie

  SymBio Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Rochelle Maher

CONTACT

+1-917-656-6951; MedInfo@symbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IT (5); PT (1); GB (8); FR (3); CA (3); BE (1); US (26); DE (7); NL (2); ES (3); SE (1)