A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorSymBio Pharmaceuticals
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
BCV
DrugBrincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Treatment groups
52 Participants
are divided into 4 treatment groupsGroup A: BCV 0.2mg/kg BIWExperimental treatment 1 intervention
Group B: BCV 0.3mg/kg BIWExperimental treatment 1 intervention
Group C: BCV 0.4 mg/kg BIWExperimental treatment 1 intervention
Group D: BCV 0.4 mg/kg QWExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
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 weeks2
Antiviral Effects
Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.
Time frame
From initiation of BCV administration up to 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov