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

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SymBio Pharmaceuticals

Criteria

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.