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Antiviral

IV BCV for Adenovirus Infections (ATHENA Trial)

Phase 2
Recruiting
Research Sponsored by SymBio Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of bcv administration up to 19 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an experimental antiviral drug to see if it is safe and tolerable for people with adenovirus infection.

Who is the study for?
This trial is for individuals aged 2 months and older with Adenovirus infection, showing high virus levels in the blood. Participants must either have a widespread infection or be immunocompromised with asymptomatic or localized disease. They should need intravenous treatment but can't join if they have severe skin reactions, gut/liver issues from graft-versus-host disease, weigh over 120 kg, or had recent severe diarrhea.
What is being tested?
The study tests different doses of an intravenous drug called Brincidofovir (BCV) to find a safe and tolerable amount for treating Adenovirus infections. It's given in increasing amounts to see how patients handle it.
What are the potential side effects?
While specific side effects for BCV are not listed here, similar antiviral drugs often cause gastrointestinal symptoms like nausea and diarrhea, potential kidney damage, and may affect liver enzymes leading to liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of bcv administration up to 19 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of bcv administration up to 19 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Antiviral Effects
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Secondary study objectives
Change AdV viremia in plasma measured from baseline up to 4 weeks
Change of Time-averaged [AdV AAUC] for AdV viremia in plasma from baseline up to 4 weeks
Peak AdV viral load in plasma after onset of AdV viremia up to 4 weeks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: BCV 0.4 mg/kg QWExperimental Treatment1 Intervention
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
Group II: BCV 0.4 mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
Group III: BCV 0.3mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
Group IV: BCV 0.2mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCV
2012
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

SymBio PharmaceuticalsLead Sponsor
22 Previous Clinical Trials
677 Total Patients Enrolled

Media Library

Brincidofovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04706923 — Phase 2
Cytomegalovirus Research Study Groups: BCV 0.2mg/kg BIW, BCV 0.3mg/kg BIW, BCV 0.4 mg/kg BIW, BCV 0.4 mg/kg QW
Cytomegalovirus Clinical Trial 2023: Brincidofovir Highlights & Side Effects. Trial Name: NCT04706923 — Phase 2
Brincidofovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706923 — Phase 2
~19 spots leftby Sep 2026
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