RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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 or Cytomegalovirus Infection

Quick Facts

Study Start:2021-08-16
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04706923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged 2 months and older at the time of informed consent.
  2. * 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.
  3. * Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
  4. * In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV.
  1. * Subjects who weigh ≥120 kg.
  2. * 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.
  3. * NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
  4. * 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.
  5. * 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.

Contacts and Locations

Study Contact

Kohji Shimasaki
CONTACT
+81-3-6684-6616
MedInfo@symbiopharma.com
Rochelle Maher
CONTACT
+1-917-656-6951
rmaher@symbiopharma.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: SymBio Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-16
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-08-16
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Adenovirus Infections
  • Cytomegalovirus Infection