A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
ATHENA
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
1 other identifier
interventional
52
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2021
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
June 21, 2024
June 1, 2024
5.1 years
January 5, 2021
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
From initiation of BCV administration up to 9 weeks
Study Arms (4)
BCV 0.2mg/kg BIW
EXPERIMENTALBCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
BCV 0.3mg/kg BIW
EXPERIMENTALBCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
BCV 0.4 mg/kg BIW
EXPERIMENTALBCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
BCV 0.4 mg/kg QW
EXPERIMENTALBCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
Interventions
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Research Site
Los Angeles, California, 90027, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
San Francisco, California, 94158, United States
Research Site
Chicago, Illinois, 60637, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Research Site
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Research Site
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 13, 2021
Study Start
August 16, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share