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

Part of paid clinical trials in Los Angeles, California.

Sponsor
SymBio Pharmaceuticals
Study ID
NCT04706923
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Adenovirus Infections
  • Cytomegalovirus Infection

Eligibility Criteria

Sex
ALL
Age
2 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCV — DRUG
    Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.

Study Details

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

Key Dates

Start date
Aug 16, 2021
Status verified
Jun 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BCV 0.2mg/kg BIW
    BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
  • Experimental: BCV 0.3mg/kg BIW
    BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
  • Experimental: BCV 0.4 mg/kg BIW
    BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
  • Experimental: BCV 0.4 mg/kg QW
    BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours

Primary Outcome Measure

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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94158-
Research SiteChicagoIllinois60637-
University of Nebraska Medical CenterOmahaNebraska68198-
Research SiteDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Research SitePhiladelphiaPennsylvania19104-
St. Jude Children's Research HospitalMemphisTennessee38105-
MD Anderson Cancer CenterHoustonTexas77030-
Research SiteSeattleWashington98109-

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By research site
Research Site· Los Angeles, CAResearch Site· San Francisco, CAResearch Site· Chicago, ILUniversity of Nebraska Medical Center· Omaha, NEResearch Site· Durham, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

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