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Antiviral

IV BCV for Adenovirus Infections

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 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of bcv administration up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with BCV treatment-related adverse events as assessed by NCI CTCAE v5.0
Secondary outcome measures
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

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 on Day1 for a minimum of 4 weeks.
Group II: BCV 0.4 mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours on Day1 and Day4 for a minimum of 4 weeks.
Group III: BCV 0.3mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours on Day1 and Day4 for a minimum of 4 weeks.
Group IV: BCV 0.2mg/kg BIWExperimental Treatment1 Intervention
BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours on Day1 and Day4 for a minimum of 4 weeks.
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
Adenovirus Infections 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
Adenovirus Infections 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for recruitment in this clinical trial?

"The latest information available on clinicaltrials.gov indicates that recruitment for this medical trial is in full swing, after initial postings were made August 16th 2021 and last updated November 14th 2022."

Answered by AI

What is the number of enrollees in this clinical investigation?

"To conduct this experiment, 24 volunteers who meet the predetermined criteria are needed. Participants may join from either Memphis, Tennessee or Omaha, Nebraska's St. Jude Children's Research Hospital."

Answered by AI

Has bacillus Calmette-Guérin been given the green light from the FDA?

"Since there is evidence of safety but none regarding efficacy, our experts at Power gave BCV a rating of 2."

Answered by AI

How widely distributed is this trial's availability?

"This trial is being conducted at Research Site in Memphis, Tennessee, St. Jude Children's Research Hospital in Omaha, Nebraska and University of Nebraska Medical Center in Houston Texas along with a further 14 sites across the country."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA)
2021. "A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04706923.
All > Adenovirus
~7 spots leftby Apr 2025
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