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

Cytomegalovirus Infection Clinical Trial

— ATHENA  

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 or Cytomegalovirus 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: September 30, 2026

Study information

• Verified date: June 2024
• 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 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 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV

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, and IV BCV in subjects with CMV.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• 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) . 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.

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus Infections
• Communicable Diseases
• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

Drug:
• BCV
Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.

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	MD Anderson Cancer Center	Houston	Texas
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	Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.	Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.	From initiation of BCV administration up to 19 weeks
Primary	Antiviral Effects	Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.	From initiation of BCV administration up to 9 weeks

External Links

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