A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCV.
- Who it may be relevant to
- Registry conditions: Adenovirus Infections, Cytomegalovirus Infection. Basic parameters: from 2 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Primary outcome measures
- Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments. [Time frame: From initiation of BCV administration up to 19 weeks]
- Antiviral Effects [Time frame: From initiation of BCV administration up to 9 weeks]
Eligibility 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Research Site — Los Angeles
- Research Site — Los Angeles
- Research Site — San Francisco
- Research Site — Chicago
- University of Nebraska Medical Center — Omaha
- Research Site — Durham
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Research Site — Philadelphia
- … and 3 more centers
Identifiers
NCT: NCT04706923 · BCV-PA01