Clinical trial

Phase II, Open-label, Randomized, Multiple Ascending Dose Confirmation of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (BASTION)

Name

BCV-BN01

Description

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.

Trial arms

Trial start

2022-10-14

Estimated PCD

2024-12-16

Trial end

2025-02-16

Status

Recruiting

Phase

Early phase I

Treatment

Brincidofovir

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

Arms:

Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW, Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW, Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase

Other names:

SyB V-1901, BCV

Size

Primary endpoint

Incidence of treatment-emergent adverse events (TEAEs)

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))

Antiviral Effects

From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))

Eligibility criteria

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 \[adefovir or tenofovir\])

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2023-02-28

1 organization

1 product

3 indications

Product

Indication

Indication

Indication

Organization

SymBio Pharmaceuticals