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

About

Brief Summary

The purpose of this study is to determine the Dose from the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) using multiple ascending doses in subjects with Adenovirus infection.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
2 Months
Maximum Age
N/A

Inclusion Criteria:

  • 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 within 7 days prior to Day 1.
  • 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:

  • 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.

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Study Stats
Protocol No.
21-001213
Category
Hematology-Oncology
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04706923
For detailed technical eligibility, visit ClinicalTrials.gov.