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

April 23, 2026 updated by: SymBio Pharmaceuticals

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase 3 multi-center, randomized, open-label study will assess efficacy of IV BCV, compared to IV CDV, in allo-HCT subjects with AdV viremia. Randomized subjects will be treated for up to a maximum of 12 weeks of therapy for both arms. Primary efficacy assessment will be performed at W5D1. Consistent with ECIL guidelines for high-risk patients, AdV viremia will be assessed weekly. Subjects randomized to receive BCV or CDV are treated until AdV DNA is confirmed to be undetectable in plasma for two consecutive tests 7 days apart, or until Week 12 post W1D1, whichever occurs first. Subjects will continue BCV or CDV as long as AdV viremia is detectable, contingent on tolerability, until viremia clears, or the subject reaches a maximum duration of 12 weeks of study drug treatment.

Subjects will receive assigned randomized therapy until time of AdV virological success plus 2 weeks, for up to a maximum of 12 weeks. All subjects will be followed through 24 weeks. All study visits and follow-up assessments must be completed regardless of the study drug treatment duration. All subjects are considered on study through the Week 24 follow-up visit.

For subjects who achieve virological success from their initial randomized study drug treatment and experience an AdV viremia recurrence, repeat treatment with their randomized study drug is allowed. There is no cross-over study drug treatment allowed in this study and subjects can only receive retreatment with their randomized study drug.

Subjects who stop study drug therapy due to confirmed undetectable AdV viremia may re-initiate study drug treatment if AdV viremia is subsequently confirmed at ≥ 1000 IU/mL by the designated central virology laboratory (recurrence). For the purposes of re-initiating study drug therapy, "confirmed viremia ≥ 1000 IU/mL" is defined as two consecutive results ≥ 1000 IU/mL from the designated central laboratory, with the second sample drawn at least 48 hours after the first sample.

Subjects who permanently discontinue study drug therapy for toxicity reasons are not eligible to re-initiate study drug dosing. Study procedures are to be followed during these Retreatment visits as applicable for BCV and CDV outlined in the schedule of assessments (SOA).

An independent Data Safety Monitoring Board (DSMB) will review accumulated safety data for this study when total combined enrollment in both arms is approximately 25% (45 subjects) and 50% (90 subjects). They will also review adverse events on an ongoing basis. They will make recommendations to the Sponsor based on review of these safety data. Further details regarding data safety monitoring guidelines will be included in the DSMB Charter. The DSMB will make determinations regarding continued enrolment and/or stopping the study for safety reasons.

An Endpoint Adjudication Committee (EAC) will be convened to evaluate baseline diagnosis and AdV disease clinical response as outlined in the EAC charter.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria
        • Not yet recruiting
        • St. Anna Kinderspital- Childrens Hospital
  • Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • Leuven, University Hospital Gasthuisberg
  • Canada
      • Calgary, Canada
        • Not yet recruiting
        • Alberta Children's Hospital University of Calgary
      • Montreal, Canada
        • Recruiting
        • CHU Sainte Justine Hospital
      • Toronto, Canada
        • Not yet recruiting
        • The Hospital for Sick Children
  • France
      • Paris, France
        • 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.
  • Germany
      • Berlin, Germany
        • Not yet recruiting
        • Charite University Hospital
      • Essen, Germany
        • Not yet recruiting
        • Essen University Hospital
      • Frankfurt, Germany
        • Not yet recruiting
        • University Hospital Frankfurt, am Main
      • Hamburg, Germany
        • Not yet recruiting
        • University Medical Center Hamburg-Eppendorf (UKE)
      • Hanover, Germany
        • Not yet recruiting
        • Medizinische Hochschule Hannover
      • Münster, Germany
        • Not yet recruiting
        • University Children's Hospital
      • Tübingen, Germany
        • Not yet recruiting
        • Kinderheilkunde I | Universitätsklinikum Tübingen
  • Italy
      • Genova, Italy
        • Not yet recruiting
        • Istituto Giannina Gaslini
      • Pavia, Italy
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San matteo
      • Perugia, Italy
        • Not yet recruiting
        • Perugia Hospital
      • Rome, Italy
        • Not yet recruiting
        • Ospedale Pediatrico Bambino Gesu'
      • San Raffaele, Italy
        • Not yet recruiting
        • IRCCS San Raffaele Hospital
  • Netherlands
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden Unviversity Medical Center
      • Utrecht, Netherlands
        • Not yet recruiting
        • Princess Maxima Center & UMC Utrecht
  • Portugal
      • Porto, Portugal
        • Not yet recruiting
        • Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Vall d'Hebron University Hospital
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Paz
      • Pamplona, Spain
        • Not yet recruiting
        • Clinica Universidad de Navarra
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska university Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Birmingham Women's and Children's Hospital
      • Leeds, United Kingdom
        • Not yet recruiting
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Not yet recruiting
        • Great Ormond Street Hospital for Children
      • Manchester, United Kingdom
        • Not yet recruiting
        • Royal Manchester Children's Hospital
      • Newcastle upon Tyne, United Kingdom
        • Not yet recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
      • Sheffield, United Kingdom
        • Not yet recruiting
        • Sheffield Children's Hospital
      • Sutton, United Kingdom
        • Not yet recruiting
        • Royal Marsden Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope
      • Sacramento, California, United States, 95616
        • Not yet recruiting
        • University of California Davis
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Not yet recruiting
        • Children's Healthcare of Atlanta/Emory
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Dana-Farber Cancer Institute-Brighman and Women's
      • Boston, Massachusetts, United States, 02139
        • Not yet recruiting
        • Dana-Farber/Boston Children's Cancer and Blood Disorders Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Not yet recruiting
        • Helen Devos Children's Hospital / Michigan State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St Louis Children's Hospital - Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68182
        • Not yet recruiting
        • University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Joseph M Sanzari Children's Hospital
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Cohen Children's Medical Center
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Weill Cornell Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Not yet recruiting
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh Medical Center Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Not yet recruiting
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV BCV
Drug: Brincidofovir
Intravenous
Other Names:
  • SyB V-1901
Active Comparator: IV CDV
Drug: cidofovir
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.
Other Names:
  • IV CDV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.
Time Frame: Week (W) 5 Day (D) 1.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.
Time Frame: Test Of Cure (Last Dose + 30 days)
The proportion of subjects with overall success, as adjuducated by the EAC
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.
Time Frame: Week 1 Day 1 Through End Of Study (Week 24).
Incidence and severity of treatment-emergent adverse events (TEAEs).
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.
Time Frame: Week 5 Day 1, Last Dose + 4 Days, Last Dose + 30 days, Week 12, and Week 24.
All cause mortality
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
Time Frame: Plasma samples will be collected at Week 1 Day 1, and Week 5 Day 1
The drug level (BCV) in plasma will be measured and used to examine the variability in drug concentrations among patients within the study population (i.e., population pharmacokinetics analysis).
Plasma samples will be collected at Week 1 Day 1, and Week 5 Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SymBio Pharmaceuticals

Investigators

  • Study Director: Nkechi Azie, SymBio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCV-PA02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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