Actively Recruiting
A Phase IIa, Open-label, Multiple Ascending Dose Study of Intravenous Brincidofovir Safety and Tolerability in Adenovirus or Cytomegalovirus Infection
Led by SymBio Pharmaceuticals · Updated on 2024-06-21
52
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of intravenous brincidofovir (BCV) in adults and children with adenovirus (AdV) or cytomegalovirus (CMV) infections. This Phase IIa, open-label study aims to confirm the effects of multiple ascending doses of BCV in subjects with AdV viremia or CMV, addressing an important need for treatment options in these viral infections. Participants receive BCV through continuous intravenous infusion over 2 hours at doses of 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg twice weekly, or 0.4 mg/kg once weekly for 4 weeks. The study includes four cohorts to assess different dosing regimens and monitors both adenovirus and cytomegalovirus infections. Throughout the study, researchers will monitor safety by tracking adverse events and laboratory tests for up to 19 weeks after starting BCV treatment. They will also evaluate antiviral effects up to 9 weeks. Participants undergo blood sampling for viral load assessments and safety labs. The total participation duration varies depending on follow-up assessments after treatment.
CONDITIONS
Brief Title
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 months and older at the time of informed consent
- Adenovirus DNA viremia >10,000 copies/mL from a single sample, or two samples over 1,000 copies/mL with increasing levels within 7 days before treatment
- Cytomegalovirus viremia with or without tissue invasive CMV disease
- Have either disseminated adenovirus disease or an immunocompromised state with asymptomatic or localized adenovirus infection
- Assessed by investigator as in serious enough condition to receive intravenous cidofovir for adenovirus
You will not qualify if you...
- Weigh 120 kg or more
- Grade 2 or higher diarrhea within 7 days prior to treatment
- Stage 4 acute graft-versus-host disease (GVHD) of the skin within 7 days prior to treatment
- Stage 2 or higher acute GVHD of the liver function within 7 days prior to treatment
- Stage 2 or higher acute GVHD of the gut, including severe diarrhea or abdominal pain, within 7 days prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 19 weeks
Participants receive intravenous Brincidofovir (BCV) at varying doses administered as continuous IV infusions to treat adenovirus or cytomegalovirus infection.
Multiple visits depending on dosing schedule up to 19 weeks
Trial Site Locations
Total: 11 locations
1
Research Site
Los Angeles, California, United States, 90027
Actively Recruiting
2
Research Site
Los Angeles, California, United States, 90095
Completed
3
Research Site
San Francisco, California, United States, 94158
Completed
4
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
Research Site
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Research Site
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
K
Kohji Shimasaki
R
Rochelle Maher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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