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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05511779
Other study ID # BCV-BN01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 14, 2022
Est. completion date February 16, 2025

Study information

Verified date November 2022
Source SymBio Pharmaceuticals
Contact Yuji Hoshino
Phone +81-3-6684-6616
Email MedInfo@symbiopharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date February 16, 2025
Est. primary completion date December 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, at least 18 years of age at the time of signing the informed consent at screening. - Kidney transplant recipient. "BK viral load increase and = 3.6 log IU/mL" at 2 weeks post immunosuppression reduction or "BK viral load does not decrease by = 0.3 log IU/mL" at 4 weeks post immunosuppression reduction during prescreening. (Note: Immunosuppressant reduction needs to be continued during the screening period). - eGFR = 30 mL/min. - Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid. Exclusion Criteria: - Subjects who weigh = 120 kg. - National Institutes of Health/NCI CTCAE Grade 2 or higher diarrhea (ie, increase of = 4 stools per day over usual pretransplant stool output) within 7 days before Day 1. - Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, = 5 µg/kg/min) dopamine for renal perfusion within 7 days before Day 1. - Use of renal replacement therapy within 7 days before Day 1. - History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives [adefovir or tenofovir])

Study Design


Intervention

Drug:
Brincidofovir
BCV 0.3 mg/kg BIW or 0.4 mg/kg BIW administered as a continuous IV infusion over 2 hours

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Austin Health Melbourne
Australia The Royal Melbourne Hospital Melbourne
Japan Tokyo Medical University Hachioji Medical Center Hachioji
Japan Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Nagoya
Japan Osaka General Medical Center Osaka
Japan Osaka Metropolitan University Hospital Osaka
Japan Hokkaido University Hospital Sapporo
Japan Sapporo City General Hospital Sapporo
Japan Jichi Medical University Hospital Shimotsuke
Japan Tokyo Women's Medical University Hospital Shinjuku-ku
Japan Osaka University Hospital Suita
Japan Fujita Health University Hospital Toyoake
Japan Yokohama City University Medical Center Yokohama

Sponsors (1)

Lead Sponsor Collaborator
SymBio Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) Incidence of TEAEs of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity and serious adverse events
Incidence of treatment-related TEAEs
Incidence of adverse events (AEs) requiring permanent discontinuation of BCV
Absolute and changes over time in safety laboratory parameters (ie, hematology, blood chemistry, and urinalysis)
from the time of administration of the first dose of study drug through the follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))
Primary Antiviral Effects Change from baseline in BK viral load in plasma measured through follow-up for each subject. Change from baseline in BK viral load in urine measured through follow-up for each subject. Peak BK viral load in plasma from Week 2 Day 1 through follow-up for each subject. Time-averaged area under the viremia-time curve for BK viral load in plasma from baseline through follow-up for each subject. From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))
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