Adenovirus InfectionsPhase 3ENOVIANCT07387367
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
A Phase 3 study testing cidofovir and Brincidofovir in people with Adenovirus Infections, run by SymBio Pharmaceuticals at 81 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Adenovirus Infections
- What is being tested?
- cidofovir and Brincidofovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 81 sitesin 13 countries
- Study dates
- 17 Mar 2026to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
81 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
81 sites in 13 countries
United States32 sites, 32 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
- Recruiting
Children's Hospital Colorado-Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
- Recruiting
Dana-Farber Cancer Institute-Brighman and Women's
Boston, Massachusetts, 02115
- Recruiting
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, 02139
- Recruiting
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, 60611
- Not yet recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Not yet recruiting
Helen Devos Children's Hospital / Michigan State University
Grand Rapids, Michigan, 49503
- Recruiting
Joseph M Sanzari Children's Hospital
Hackensack, New Jersey, 07601
- Recruiting
Riley Children's Health (Indiana University)
Indianapolis, Indiana, 46202
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
- Recruiting
Medical College of Wisconsin / Children's Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Cohen Children's Medical Center
New Hyde Park, New York, 11042
- Not yet recruiting
Columbia University Irving Medical Center
New York, New York, 10032
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
- Recruiting
University of Nebraska
Omaha, Nebraska, 68182
- Recruiting
Stanford Medicine Children's Health
Palo Alto, California, 94304
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Not yet recruiting
University of Pittsburgh Medical Center Children's Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
University of California Davis
Sacramento, California, 95616
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
St Louis Children's Hospital - Barnes Jewish Hospital
St Louis, Missouri, 63110
- Not yet recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
France9 sites, 9 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin
Bordeaux
- Recruiting
Hopital Jeanne de Flandre
Lille
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy (CHRU) - Hopitaux de Brabois - Hôpital d'enfants
Nancy
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Nantes - Hôpital Mère-Enfants
Nantes
- Recruiting
Hôpital Saint-Louis
Paris
- Recruiting
Necker Hospital
Paris
- Recruiting
Robert-Debré Hospital, APHP Nord Université de Paris Cité.
Paris
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Rennes - Hôpital Sud
Rennes
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg
Germany8 sites, 8 recruiting
- Recruiting
Charité University Hospital
Berlin
- Recruiting
Essen University Hospital
Essen
- Recruiting
University Hospital Frankfurt, am Main
Frankfurt
- Not yet recruiting
University Medical Center Freiburg
Freiburg im Breisgau
- Recruiting
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg
- Recruiting
Medizinische Hochschule Hannover
Hanover
- Recruiting
University Children's Hospital
Münster
- Not yet recruiting
Kinderheilkunde I | Universitätsklinikum Tübingen
Tübingen
United Kingdom8 sites, 8 recruiting
- Not yet recruiting
Birmingham Women's and Children's Hospital
Birmingham
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
- Recruiting
Great Ormond Street Hospital for Children
London
- Recruiting
University College London Hospitals NHS Foundation Trust
London
- Recruiting
Royal Manchester Children's Hospital
Manchester
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne
- Recruiting
Sheffield Children's Hospital
Sheffield
- Recruiting
Royal Marsden Hospital
Sutton
Canada6 sites, 6 recruiting
- Recruiting
Alberta Children's Hospital University of Calgary
Calgary
- Recruiting
Hopital Maisonneuve-Rosemont - CIUSSS de l Est de L Ile de Montreal
Montreal, Quebec Province
- Not yet recruiting
Montreal Children's Hospital - McGill University Health Centre
Montreal, Quebec Province
- Recruiting
CHU Sainte Justine Hospital
Montreal
- Recruiting
University Health Network- Princess Margaret Cancer Centre
Toronto, Ontario Province
- Recruiting
The Hospital for Sick Children
Toronto
Italy5 sites, 5 recruiting
- Recruiting
Istituto Giannina Gaslini
Genova
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
- Recruiting
Perugia Hospital
Perugia
- Recruiting
Ospedale Pediatrico Bambino Gesu'
Rome
- Recruiting
IRCCS San Raffaele Hospital
San Raffaele
Spain4 sites, 4 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona
- Recruiting
Hospital Universitario La Paz
Madrid
- Recruiting
Clinica Universidad de Navarra
Pamplona
- Recruiting
Hospital Universitario de Salamanca
Salamanca
Belgium2 sites, 2 recruiting
- Not yet recruiting
Leuven, University Hospital Gasthuisberg
Leuven
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Liège
Liège
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Leiden Unviversity Medical Center
Leiden
- Not yet recruiting
Princess Maxima Center & UMC Utrecht
Utrecht
Portugal2 sites, 2 recruiting
- Not yet recruiting
Instituto Português de Oncologia de Lisboa (IPO Lisboa) Francisco Gentil, EPE
Lisbon
- Not yet recruiting
Instituto Português de Oncologia do Porto (IPO Porto) Francisco Gentil, EPE
Porto
Austria1 site, 1 recruiting
- Not yet recruiting
St. Anna Kinderspital- Childrens Hospital
Vienna
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
About this study
Official title: 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.
Read the 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.
- Conditions
- Adenovirus Infections
- Being tested
- cidofovir, Brincidofovir
- Keywords
- Brincidofovir, Cidofovir, Adenovirus, allo-HCT, BCV-PA02, ENOVIA
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cidofovirDrug
Also called IV CDV
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.
BrincidofovirDrug
Also called SyB V-1901
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| IV BCV | Experimental | Not described Receives: Drug: Brincidofovir |
| IV CDV | Active comparator | Not described Receives: Drug: cidofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The proportion of subjects with overall success, as adjuducated by the EAC
Measured: 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.
Incidence and severity of treatment-emergent adverse events (TEAEs).
Measured: 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.
All cause mortality
Measured: 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
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).
Measured: Plasma samples will be collected at Week 1 Day 1, and Week 5 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Mar 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minori Rosales, Study director, SymBio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387367
- Sponsor's protocol ID
- BCV-PA02
- Acronym
- ENOVIA
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07387367
- Acronym / sponsor ID
- ENOVIA / BCV-PA02
- Conditions
- Adenovirus Infections
- Keywords
- Brincidofovir, Cidofovir, Adenovirus, allo-HCT, BCV-PA02, ENOVIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV BCV | Experimental | Drug: Brincidofovir |
| IV CDV | Active comparator | Drug: cidofovir |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cidofovirAlso: IV CDVCDV does not have a labeled indication for treating Adenovirus infection. CDV will be administered according to local guidelines and institutional standard of care practice. | Drug | IV CDV |
| BrincidofovirAlso: SyB V-1901Intravenous | Drug | IV BCV |
Primary outcome
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
4 secondary outcomes
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)
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).
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minori Rosales study director
SymBio Pharmaceuticals
81 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cidofovir and Brincidofovir in people with Adenovirus Infections, run by SymBio Pharmaceuticals at 81 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, France, Germany, United Kingdom, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rochelle Maher (+1-917-656-6951, MedInfo@symbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.