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

Purpose

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

Conditions

  • Adenovirus Infections
  • Cytomegalovirus Infection

Eligibility

Eligible Ages
Over 2 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BCV 0.2mg/kg BIW 		BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
  • Drug: BCV
    Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Experimental
BCV 0.3mg/kg BIW 		BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
  • Drug: BCV
    Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Experimental
BCV 0.4 mg/kg BIW 		BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
  • Drug: BCV
    Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Experimental
BCV 0.4 mg/kg QW 		BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
  • Drug: BCV
    Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.

Recruiting Locations

Research Site
Los Angeles, California 90027

Research Site
Chicago, Illinois 60637

University of Nebraska Medical Center
Omaha, Nebraska 68198

Research Site
Durham, North Carolina 27710

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Research Site
Philadelphia, Pennsylvania 19104

St. Jude Children's Research Hospital
Memphis, Tennessee 38105

MD Anderson Cancer Center
Houston, Texas 77030

Research Site
Seattle, Washington 98109

More Details

Status
Recruiting
Sponsor
SymBio Pharmaceuticals

Study Contact

Kohji Shimasaki
+81-3-6684-6616
MedInfo@symbiopharma.com

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.