Summary

Eligibility
for people ages 2 months and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jasmeen Dara

Description

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.

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

Details

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. A total of 24 subjects aged 2 months and older will be enrolled: 6 subjects to each Cohort.

Keywords

Adenovirus Infection, Infections, Communicable Diseases, Adenoviridae Infections, BCV, BCV 0.2mg/kg BIW, BCV 0.3mg/kg BIW, BCV 0.4 mg/kg BIW, BCV 0.4 mg/kg QW

Eligibility

You can join if…

Open to people ages 2 months and up

  • 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.

You CAN'T join 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.

Locations

  • Research Site accepting new patients
    San Francisco California 94158 United States
  • Research Site accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSF

  • Jasmeen Dara
    Assistant Professor, Pediatrics, School of Medicine. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SymBio Pharmaceuticals
Links
Related Info
ID
NCT04706923
Phase
Phase 2 Adenovirus Research Study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated