Adenovirus InfectionsPhase 2ATHENANCT04706923
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
A Phase 2 study testing BCV in people with Adenovirus Infections and Cytomegalovirus Infection, run by SymBio Pharmaceuticals at 11 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Adenovirus Infections, Cytomegalovirus Infection
- What is being tested?
- BCV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Aug 2021to 15 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Research Site
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Research Site
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Research Site
Los Angeles, California, 90027
Research Site
Los Angeles, California, 90095
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
San Francisco, California, 94158
Research Site
Seattle, Washington, 98109
About this study
Official title: A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV
Read the detailed description
This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia, and IV BCV in subjects with CMV.
- Conditions
- Adenovirus Infections, Cytomegalovirus Infection
- Being tested
- BCV
- Medical subject headings
- Adenoviridae Infections, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCVDrug
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
| Study group | Role | What they receive |
|---|---|---|
| BCV 0.2mg/kg BIW | Experimental | BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| BCV 0.3mg/kg BIW | Experimental | BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| BCV 0.4 mg/kg BIW | Experimental | BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| BCV 0.4 mg/kg QW | Experimental | BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| 0.4 mg/kg BIW | Experimental | BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| 0.5 mg/kg BIW | Experimental | BCV: 0.5 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
| 0.6 mg/kg BIW | Experimental | BCV: 0.6 mg/kg administered as a continuous IV infusion over 2 hours Receives: Drug: BCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Measured: From initiation of BCV administration up to 19 weeks
Antiviral Effects
Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.
Measured: From initiation of BCV administration up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start16 Aug 2021
- Primary completion15 May 2025
- Study completion15 May 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706923
- Sponsor's protocol ID
- BCV-PA01
- Acronym
- ATHENA
- Status last verified
- Aug 2026
- First submitted
- 5 Jan 2021
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT04706923
- Acronym / sponsor ID
- ATHENA / BCV-PA01
- Conditions
- Adenovirus Infections, Cytomegalovirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 13 Jan 2021 (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.
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV
Detailed description
This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia, and IV BCV in subjects with CMV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BCV 0.2mg/kg BIW | Experimental | Drug: BCVBCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours |
| BCV 0.3mg/kg BIW | Experimental | Drug: BCVBCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours |
| BCV 0.4 mg/kg BIW | Experimental | Drug: BCVBCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours |
| BCV 0.4 mg/kg QW | Experimental | Drug: BCVBCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours |
| 0.4 mg/kg BIW | Experimental | Drug: BCVBCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours |
| 0.5 mg/kg BIW | Experimental | Drug: BCVBCV: 0.5 mg/kg administered as a continuous IV infusion over 2 hours |
| 0.6 mg/kg BIW | Experimental | Drug: BCVBCV: 0.6 mg/kg administered as a continuous IV infusion over 2 hours |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| BCVBrincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug. | Drug | 0.4 mg/kg BIW, 0.5 mg/kg BIW, 0.6 mg/kg BIW, BCV 0.2mg/kg BIW, BCV 0.3mg/kg BIW, BCV 0.4 mg/kg BIW, BCV 0.4 mg/kg QW |
Primary outcome
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Time frame: 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 Effects
Time frame: From initiation of BCV administration up to 9 weeks
Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCV in people with Adenovirus Infections and Cytomegalovirus Infection, run by SymBio Pharmaceuticals at 11 sites in United States.
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 4 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments. (time frame: From initiation of BCV administration up to 19 weeks). The study lists 2 primary outcomes in all. 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 11 Aug 2026.