Testing a new treatment for adenovirus infections
A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection
This study is testing a new treatment called brincidofovir to see if it can safely help adults and children with adenovirus and cytomegalovirus infections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 2 Months and up |
| Sex | All |
| Sponsor | SymBio Pharmaceuticals Industry-sponsored |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT04706923 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of intravenous brincidofovir (BCV) in patients with adenovirus (AdV) and cytomegalovirus (CMV) infections. Participants will receive different doses of BCV either twice weekly or once weekly for four weeks. The study is open-label and involves multiple ascending doses to confirm the appropriate dosing regimen. It aims to gather data on the drug's effects in both adult and pediatric subjects with significant viral loads.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 2 months and older with significant adenovirus or cytomegalovirus viremia.
Not a fit: Patients without detectable adenovirus or cytomegalovirus infections or those who are not immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from adenovirus and cytomegalovirus infections.
How similar studies have performed: While this approach is being tested in this specific context, similar antiviral treatments have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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. Exclusion Criteria: * 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. * NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \>556 mL/m2/day for pediatric subjects \[or \>1000 mL/day for young adults as applicable, at centers in the United States only\], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
Where this trial is running
Los Angeles, California and 10 other locations
- Research Site — Los Angeles, California, United States (Recruiting)
- Research Site — Los Angeles, California, United States (Completed)
- Research Site — San Francisco, California, United States (Completed)
- Research Site — Chicago, Illinois, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Research Site — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Research Site — Philadelphia, Pennsylvania, United States (Recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Research Site — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Kohji Shimasaki
- Email: MedInfo@symbiopharma.com
- Phone: +81-3-6684-6616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.