A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
NCT ID: NCT04706923
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
52 participants
INTERVENTIONAL
2021-08-16
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BCV 0.2mg/kg BIW
BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
BCV 0.3mg/kg BIW
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
BCV 0.4 mg/kg BIW
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
BCV 0.4 mg/kg QW
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Interventions
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BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
2 Months
ALL
No
Sponsors
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SymBio Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Chicago, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Research Site
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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BCV-PA01
Identifier Type: -
Identifier Source: org_study_id
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