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

NCT05837338 | Completed Phase 2 FDA Drug

• 1 other identifier: BXP154-PIL
• 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, 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?

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 (13)

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

Sequence A

EXPERIMENTAL

Single topical application of BXP154 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2

Drug: BXP154; Drug: Placebo

Sequence B

EXPERIMENTAL

Single topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154 6ml (left leg), treatment period 2

Drug: BXP154; Drug: Placebo

Sequence C

EXPERIMENTAL

Single topical application of BXP154 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2

Drug: BXP154; Drug: Placebo

Sequence D

EXPERIMENTAL

Single topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154 6ml (right leg), treatment period 2

Drug: BXP154; Drug: Placebo

Interventions

BXP154 DRUG

BXP154 will be self-administered topically following wound induction

Sequence A; Sequence B; Sequence C; Sequence D

Placebo DRUG

Placebo will be self-administered topically following wound induction

Sequence A; Sequence B; Sequence C; Sequence D

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 anticoagulant therapy at the permitted therapeutic dose as described below, and who have been on the same anticoagulant for ≥30 days prior to Screening Permitted anticoagulants and doses include: Warfarin, any dose as prescribed as long as the International Normalized Ratio (INR) criteria are met; apixaban (Eliquis®), 10 mg total daily dose; or rivaroxaban (Xarelto®), ≥15 mg total daily dose
• Subjects on Warfarin must meet INR therapeutic range: INR 2-3.5
• 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 BXP154
• 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.
• 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

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: March 24, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)