A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Recruiting now · Phase 2
Conditions studied: Adenovirus Infections, Cytomegalovirus Infection
In brief
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
Key facts
- Study ID
- NCT04706923
- Run by
- SymBio Pharmaceuticals
- People needed
- 52
- Starts
- 2021-08-16
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-06-21
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Research Site — Seattle, Washington, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Research Site — Los Angeles, California, United States (enrolling)
- Research Site — Chicago, Illinois, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Research Site — Durham, North Carolina, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Research Site — Philadelphia, Pennsylvania, United States (enrolling)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
- Research Site — Los Angeles, California, United States
- Research Site — San Francisco, California, United States
Full record on ClinicalTrials.gov
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