NCT05837338

Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bio 54, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test if the study drug, BXP154 works to stop bleeding from a minor wound in patients that are on anticoagulant therapy. The main questions it aims to answer are: * How long does it take to stop bleeding after BXP154 is applied to a wound? * How many people require the use of a rescue treatment to stop bleeding? * Does BXP154 reduce instances of re-bleeding after the bleeding has stopped initially? * Is BXP154 safe and well-tolerated?

Detailed description

Oral anticoagulant-related clinically relevant nonmajor bleeding (CRNMB; i.e., non-major bleeding that requires medical intervention, increased level of care, or face-to-face evaluation) and minor bleeding, often referred to as 'nuisance' bleeding, carries a high burden in terms of patient discomfort, anxiety, temporary disability, and reduced quality of life, and strain on medical and socioeconomic resources. Prolonged bleeding following minor injuries (falls, scrapes, cuts) can be life-interrupting and frequently leads patients to seek medical care, often times in an urgent care or emergency department (ED) setting. Prolonged bleeding from minor injuries is a significant challenge to daily life for people on anticoagulants, and is anything but 'minor' to the patient. Bio 54, LLC, is developing BXP154, a topical agent intended for self-administration (in or outside the home) to treat external bleeding from minor wounds in patients on anticoagulants. The development of BXP154 will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home. BXP154-PIL is a randomized, double-blind, placebo-controlled, 2-way crossover-design study to evaluate the efficacy, safety, and pharmacokinetics of BXP154 (1500 mg/6 mL) compared with volume-matched placebo in the treatment of bleeding following punch biopsy in anticoagulated subjects. Subjects will be enrolled in this clinical trial for a total of nine days, following a screening period of up to 28 days. The study commences on Day 1 with a skin punch biopsy and administration of the investigational drug or placebo. Subsequently, follow-up assessments will be conducted on Days 2, 3, and 4. A second skin punch biopsy will be performed on Day 4, followed by additional follow-up assessments on Days 5, 6, 7,and 9. Upon completion of the Day 9 assessments, subjects will have fulfilled their involvement in the study.

Conditions

• Wound Bleeding

Interventions

Type	Name	Description
DRUG	BXP154	BXP154 will be self-administered topically following wound induction
DRUG	Placebo	Placebo will be self-administered topically following wound induction

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2023-05-01
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study