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NCT04706923PHASE2Recruiting

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

SymBio Pharmaceuticals

Start Date

8/16/2021

Completion Date

9/30/2026

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 once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV

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 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, and IV BCV in subjects with CMV.

Eligibility Criteria

Age Range: No minimum to No maximum

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 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 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.

Interventions

DRUG

BCV

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Conditions

Adenovirus InfectionsCytomegalovirus Infection

Locations

Research Site

Los Angeles, California 90027

United States

Research Site

Los Angeles, California 90095

United States

Research Site

San Francisco, California 94158

United States

Research Site

Chicago, Illinois 60637

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Research Site

Durham, North Carolina 27710

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Research Site

Philadelphia, Pennsylvania 19104

United States

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Research Site

Seattle, Washington 98109

United States