Actively Recruiting
Safety and Tolerability Study of Intravenous Brincidofovir for Adenovirus and Cytomegalovirus Infections Phase IIa Open-Label Multi-Dose Study
Led by SymBio Pharmaceuticals · Updated on 2024-06-21
52
Participants Needed
11
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase IIa, open-label study to evaluate the safety and tolerability of intravenous brincidofovir (BCV) in adults and children with adenovirus (AdV) or cytomegalovirus (CMV) infections. The study focuses on subjects with AdV viremia or CMV viremia, including those with tissue-invasive CMV disease or immunocompromised states. The goal is to assess different dosing regimens of BCV and its effects on these viral infections. Participants will receive intravenous BCV at doses of 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg either twice weekly or once weekly for four weeks. The study includes multiple cohorts to confirm the optimal dosing schedule. Brincidofovir, a lipid conjugate of cidofovir, is designed to improve drug delivery inside cells. Treatment is given across several centers and includes both adult and pediatric patients. Throughout the study, researchers will monitor for safety by tracking adverse events, serious adverse events, and laboratory results from the start of BCV administration up to 19 weeks. Antiviral effects will also be evaluated up to 9 weeks. Participants will undergo blood tests to measure viral loads and assess overall health. The total follow-up period allows close observation of treatment impact and safety over several months.
CONDITIONS
Official 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 greater than 10,000 copies/mL from a single sample, or two samples more than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, collected within 7 days prior to Day 1
- Cytomegalovirus viremia with or without evidence of tissue-invasive CMV disease
- Have either disseminated adenovirus disease or an underlying immunocompromised state with asymptomatic or localized adenovirus infection
- Considered by the investigator to be in serious condition warranting treatment with intravenous cidofovir for adenovirus
You will not qualify if you...
- Subjects who weigh 120 kg or more
- Grade 2 or higher diarrhea (increase of 4 or more stools per day over usual pre-transplant output) within 7 days prior to Day 1
- NIH Stage 4 acute graft-versus-host disease of the skin within 7 days prior to Day 1
- NIH Stage 2 or higher acute graft-versus-host disease of the liver (bilirubin greater than 3 mg/dL) within 7 days prior to Day 1
- NIH Stage 2 or higher acute graft-versus-host disease of the gut (diarrhea greater than 556 mL/m2/day for pediatric subjects or greater than 1000 mL/day for young adults, or severe abdominal pain with or without ileus) within 7 days prior to Day 1
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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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