A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA)

Adenovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706923
• Other study ID #: BCV-PA01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: SymBio Pharmaceuticals
• Contact: Kohji Shimasaki
• Phone: +81-3-6684-6616
• Email: MedInfo[@]symbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the Dose from the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) using multiple ascending doses in subjects with Adenovirus infection.

Description:

This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia. A total of 24 subjects aged 2 months and older will be enrolled: 6 subjects to each Cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months and older

Eligibility

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) .
• 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.

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus Infection
• Communicable Diseases
• Infections

Intervention

Drug:
• BCV
BCV 0.2 mg/kg BIW, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW via IV infusion for 2 hours

Locations

Country	Name	City	State
United States	Research Site	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Research Site	Durham	North Carolina
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	San Francisco	California
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with BCV treatment-related adverse events as assessed by NCI CTCAE v5.0		From initiation of BCV administration up to 4 weeks
Secondary	Change AdV viremia in plasma measured from baseline up to 4 weeks		From initiation of BCV administration up to 4 weeks
Secondary	Change of Time-averaged [AdV AAUC] for AdV viremia in plasma from baseline up to 4 weeks		From initiation of BCV administration up to 4 weeks
Secondary	Peak AdV viral load in plasma after onset of AdV viremia up to 4 weeks		From initiation of BCV administration up to 4 weeks

External Links

•   Related Info