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Phase 2a Study of IV Brincidofovir for Adenovirus and Cytomegalovirus Infections

This study is testing an intravenous (IV) medication called brincidofovir (BCV) in people with adenovirus (AdV) or cytomegalovirus (CMV) infections. Researchers want to see how safe brincidofovir is and how well people tolerate different doses (0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg) given either twice a week or once a week for four weeks. The study will also look at how effective brincidofovir is against the viruses. To join, you must be at least 2 months old and have a certain level of AdV DNA in your blood. The study aims to enroll 52 participants.

Study design
This is a Phase 2a, open-label study, meaning both you and your doctors will know which dose of brincidofovir you are receiving. It is a multicenter study planning to enroll 52 participants.
What's involved
You would receive intravenous brincidofovir either twice weekly or once weekly for 4 weeks. You would also have laboratory assessments and monitoring for side effects.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 19 weeks after starting brincidofovir. Antiviral effects will be measured for up to 9 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04706923

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection

Completed
PHASE2Ages 2+InterventionalTreatment
SymBio Pharmaceuticals
~53 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:BCV

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Measured over From initiation of BCV administration up to 19 weeks
+1 more outcome measured

Conditions

Adenovirus Infections
Cytomegalovirus Infection

Explore related trials

Adenovirus InfectionCytomegaloviral InfectionAdV DNACytomegaloviral Infection

Where it's being run

11 sites across 9 states
California3
Illinois1
Nebraska1
North Carolina1
Ohio1
Pennsylvania1
Tennessee1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, aged 2 months and older at the time of informed consent.
AdV DNA viremia \>10,000 copies/mL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or without evidence of tissue invasive CMV disease. For laboratory results that are generated in units other than copies/mL or IU/mL, please refer to the testing laboratory for guidance on the appropriate conversion calculation.
Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV.

Exclusion

Subjects who weigh ≥120 kg.
NIH/NCI CTCAE (United States \[US\] National Institutes of Health \[NIH\]/National Cancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to Day 1.
NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin \>3 mg/dL \[SI: \>51 μmol/L\]) within 7 days prior to Day 1.
NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \>556 mL/m2/day for pediatric subjects \[or \>1000 mL/day for young adults as applicable, at centers in the United States only\], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.

What this trial measures

  • Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.From initiation of BCV administration up to 19 weeks

    Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.

  • Antiviral EffectsFrom initiation of BCV administration up to 9 weeks

    Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.