Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B

NCT06205615 | Completed Phase 2 FDA Drug

• 1 other identifier: BXP154-201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test if the study drug, BXP154B works to stop bleeding from a minor wound in patients that are on apixaban for anticoagulant therapy. The main questions it aims to answer are:

• How long does it take to stop bleeding after BXP154B is applied to a wound?
• How many people require the use of a rescue treatment to stop bleeding?
• Does BXP154B reduce instances of re-bleeding after the bleeding has stopped initially?
• Is BXP154B safe and well-tolerated?

Conditions

Wound Bleeding

Keywords

Anticoagulant

Outcome Measures

Primary Outcomes (1)

• Time to achieve hemostasis (in minutes) following start of treatment

  Time to achieve hemostasis (in minutes) will be compared between active treatment and control.

  60 minutes following start of treatment

Secondary Outcomes (11)

• Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 40 mins, 50mins, 60mins

  60 minutes following start of treatment

• Proportion of subjects who require rescue treatment intervention to achieve hemostasis following biopsy

  60 minutes following start of treatment

• Time to achieve hemostasis (in minutes) with no rebleeding requiring self-managed or medical intervention within 72 hours after the start of treatment

  72 hours following start of treatment

• Proportion of subjects who experience rebleeding following initial hemostasis that requires self-managed or medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment

  72 hours following start of treatment

• Proportion of subjects who experience rebleeding following initial hemostasis that requires subsequent self-managed intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment

  72 hours following start of treatment

Study Arms (4)

Punch Biopsy + BXP154B/Right Leg Period 1; Punch Biopsy + Placebo/Left Leg Period 2

EXPERIMENTAL

Single topical application of BXP154B 6ml after punch biopsy (right leg), treatment period 1; single topical application of Placebo 6ml after punch biopsy (left leg), treatment period 2

Drug: BXP154B; Drug: Placebo; Procedure: Punch Biopsy

Punch Biopsy + Placebo/Right Leg Period 1; Punch Biopsy + BXP154B/Left Leg Period 2

EXPERIMENTAL

Single topical application of Placebo 6ml after punch biopsy (right leg), treatment period 1; single topical application of BXP154B 6ml after punch biopsy (left leg), treatment period 2

Drug: BXP154B; Drug: Placebo; Procedure: Punch Biopsy

Punch Biopsy + BXP154B/Left Leg Period 1; Punch Biopsy + Placebo/Right Leg Period 2

EXPERIMENTAL

Single topical application of BXP154B 6ml after punch biopsy (left leg), treatment period 1; single topical application of Placebo 6ml after punch biopsy (right leg), treatment period 2

Drug: BXP154B; Drug: Placebo; Procedure: Punch Biopsy

Punch Biopsy + Placebo/Left Leg Period 1; Punch Biopsy + BXP154B/Right Leg Period 2

EXPERIMENTAL

Single topical application of Placebo 6ml after punch biopsy (left leg), treatment period 1; single topical application of BXP154B 6ml after punch biopsy (right leg), treatment period 2

Drug: BXP154B; Drug: Placebo; Procedure: Punch Biopsy

Interventions

BXP154B DRUG

BXP154B will be self-administered topically following wound induction

Punch Biopsy + BXP154B/Left Leg Period 1; Punch Biopsy + Placebo/Right Leg Period 2; Punch Biopsy + BXP154B/Right Leg Period 1; Punch Biopsy + Placebo/Left Leg Period 2; Punch Biopsy + Placebo/Left Leg Period 1; Punch Biopsy + BXP154B/Right Leg Period 2; Punch Biopsy + Placebo/Right Leg Period 1; Punch Biopsy + BXP154B/Left Leg Period 2

Placebo DRUG

Placebo will be self-administered topically following wound induction

Punch Biopsy + BXP154B/Left Leg Period 1; Punch Biopsy + Placebo/Right Leg Period 2; Punch Biopsy + BXP154B/Right Leg Period 1; Punch Biopsy + Placebo/Left Leg Period 2; Punch Biopsy + Placebo/Left Leg Period 1; Punch Biopsy + BXP154B/Right Leg Period 2; Punch Biopsy + Placebo/Right Leg Period 1; Punch Biopsy + BXP154B/Left Leg Period 2

Punch Biopsy PROCEDURE

Punch biopsy to leg

Punch Biopsy + BXP154B/Left Leg Period 1; Punch Biopsy + Placebo/Right Leg Period 2; Punch Biopsy + BXP154B/Right Leg Period 1; Punch Biopsy + Placebo/Left Leg Period 2; Punch Biopsy + Placebo/Left Leg Period 1; Punch Biopsy + BXP154B/Right Leg Period 2; Punch Biopsy + Placebo/Right Leg Period 1; Punch Biopsy + BXP154B/Left Leg Period 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age on the day of signed informed consent. At least 8 subjects of each sex will be enrolled.
• Currently receiving apixaban (Eliquis®) and on a BID dosing regimen 5 mg BID (10 mg total daily dose). Subjects must have been on the same dosing regimen for at least 7 days prior to Day 1.
• Willing and able to provide informed consent prior to any study procedures and to comply with all aspects of the protocol

You may not qualify if:

• Allergy or sensitization to any components of BXP154B
• BMI ≥ 50 kg/m2
• Known genetic/familial hypercoagulable disorder
• Thrombocytopenia (platelets \<75,000/mm3)
• Subjects using any prescribed chronic drug therapies that impact platelet function including clopidogrel (Plavix®), prasugrel (Effient®), ticagrelor (Brillinta®), dipyridamole (Aggrenox®), cilostazol (Pletal®), aspirin, or any non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, diclofenac, indomethacin, ketorolac, etc.) are excluded from participation in the study. NSAIDs or aspirin taken on an as needed (PRN) basis must be discontinued according to the following required windows prior to Day 1 (aspirin, 7 days; ibuprofen, 24 hours; all other NSAIDs, 4 days) and may not be taken for the duration of the study.
• Use of any other anticoagulant therapies other than apixaban 5mg BID
• Hypersensitivity to any local anesthetic being used by the site
• Pregnant, breastfeeding, or planning to become pregnant
• Use of any hormonal contraceptive methods (e.g., oral, injectable, vaginal ring, transdermal patch, or hormonal intrauterine device \[IUD\]), or any oral treatment containing estrogen or synthetic estrogen within 30 days prior to Screening or during study participation. Women of childbearing potential must agree to use effective non-hormonal contraception during study participation.
• Participation in another clinical trial for an investigational product within 30 days prior to Screening. In addition, subjects who participated in BXP154-PIL are not eligible for this study.
• Any clinically significant finding on screening assessments or other physical or neurological condition that, in the opinion of the investigator, impairs the ability of the subject to comply with protocol procedures and safely participate in the study

Sponsors & Collaborators

• Bio 54, LLC: lead

Study Sites (1)

Accel Research Sites Network - DeLand

DeLand, Florida, 32720, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, 2-way crossover

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: January 24, 2024
• Primary Completion: March 14, 2024
• Study Completion: March 18, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)