Status:
RECRUITING
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Lead Sponsor:
SymBio Pharmaceuticals
Conditions:
Adenovirus Infections
Cytomegalovirus Infection
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04706923
Start Date
August 16 2021
End Date
September 30 2026
Last Update
June 21 2024
Active Locations (11)
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1
Research Site
Los Angeles, California, United States, 90027
2
Research Site
Los Angeles, California, United States, 90095
3
Research Site
San Francisco, California, United States, 94158
4
Research Site
Chicago, Illinois, United States, 60637