NCT04706923 · SymBio Pharmaceuticals
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
(ATHENA)
What this study is about
The purpose of this study is to determine the safety and how well patients handle the treatment of given through a vein (IV) (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.
View original scientific description
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.
Interventions
DRUG
BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.
Primary outcome measures
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
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Antiviral Effects
Time frame: From initiation of BCV administration up to 9 weeks
Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 as
Where
- Los Angeles, California
- San Francisco, California
- Chicago, Illinois
- Omaha, Nebraska
- Durham, North Carolina
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
- Memphis, Tennessee
- Houston, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 21, 2024 · Source of record for eligibility and locations