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

Recruiting Phase 2 Interventional Study
Adenovirus Infections Cytomegalovirus Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 Months and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
SymBio Pharmaceuticals · Industry
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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

Trial Locations
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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 obtaine…
Contacts

Kohji Shimasaki

+81-3-6684-6616

MedInfo@symbiopharma.com

CONTACT

Rochelle Maher

+1-917-656-6951

rmaher@symbiopharma.com

CONTACT