Wound BleedingPhase 2NCT06205615
Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B
A Phase 2 study testing BXP154B and Punch Biopsy in people with Wound Bleeding, run by Bio 54, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Bleeding
- What is being tested?
- BXP154B and Punch Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 18 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Accel Research Sites Network - DeLand
DeLand, Florida, 32720
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of BXP154B (Tranexamic Acid Sterile Topical Solution) in the Treatment of External Bleeding From Minor Wounds in Subjects on Apixaban
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?
Read the 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 BXP154B, 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 BXP154B will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home.
BXP154-201 is a randomized, double-blind, placebo-controlled, 2-way crossover-design study to evaluate the efficacy and safety of BXP154B (6 mL) compared with volume-matched placebo in the treatment of bleeding following punch biopsy in subjects on apixaban.
Subjects will be enrolled in this clinical trial for a total of seven 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, and 7. Upon completion of the Day 7 assessments, subjects will have fulfilled their involvement in the study.
- Conditions
- Wound Bleeding
- Being tested
- BXP154B, Placebo, Punch Biopsy
- Keywords
- Anticoagulant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXP154BDrug
BXP154B will be self-administered topically following wound induction
PlaceboDrug
Placebo will be self-administered topically following wound induction
Punch BiopsyProcedure or surgery
Punch biopsy to leg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: BXP154B; Drug: Placebo; Procedure: Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve hemostasis (in minutes) following start of treatment
Time to achieve hemostasis (in minutes) will be compared between active treatment and control.
Measured: 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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Measured: 60 minutes following start of treatment
Proportion of subjects who require rescue treatment intervention to achieve hemostasis following biopsy
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Measured: 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
Time (in minutes) to achieve hemostasis will be compared between active treatment and control.
Measured: 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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Measured: 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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Measured: 72 hours following start of treatment
Proportion of subjects who experience rebleeding following initial hemostasis that requires subsequent medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Measured: 72 hours following start of treatment
Number of rebleeding episodes following initial hemostasis that require subsequent medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment
Summarized as the number of episodes per subject compared between active treatment and control.
Measured: 72 hours following start of treatment
Time to achieve hemostasis (in minutes) following the start of treatment in subjects with a bleed time of at least 10 minutes in either treatment period
Time (in minutes) to achieve hemostasis will be compared between active treatment and control.
Measured: 72 hours following start of treatment
Proportion of subjects who experience adverse events including adverse skin reactions and other clinically significant findings on physical exam; clinically significant lab values; and clinically significant changes in vital signs.
Summarized as the proportion of subjects reporting adverse events compared between active treatment and control.
Measured: 9 days
Systolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Measured: 7 days
Diastolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start24 Jan 2024
- Primary completion14 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, 2-way crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio 54, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205615
- Sponsor's protocol ID
- BXP154-201
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of BXP154B (Tranexamic Acid Sterile Topical Solution) in the Treatment of External Bleeding From Minor Wounds in Subjects on Apixaban
- ClinicalTrials.gov ID
- NCT06205615
- Acronym / sponsor ID
- BXP154-201
- Conditions
- Wound Bleeding
- Keywords
- Anticoagulant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bio 54, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 BXP154B, 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 BXP154B will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home.
BXP154-201 is a randomized, double-blind, placebo-controlled, 2-way crossover-design study to evaluate the efficacy and safety of BXP154B (6 mL) compared with volume-matched placebo in the treatment of bleeding following punch biopsy in subjects on apixaban.
Subjects will be enrolled in this clinical trial for a total of seven 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, and 7. Upon completion of the Day 7 assessments, subjects will have fulfilled their involvement in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, 2-way crossover
| Arm | Type | Receives |
|---|---|---|
| Punch Biopsy + BXP154B/Right Leg Period 1; Punch Biopsy + Placebo/Left Leg Period 2 | Experimental | Drug: BXP154B, Drug: Placebo, Procedure: Punch BiopsySingle 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 |
| Punch Biopsy + Placebo/Right Leg Period 1; Punch Biopsy + BXP154B/Left Leg Period 2 | Experimental | Drug: BXP154B, Drug: Placebo, Procedure: Punch BiopsySingle 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 |
| Punch Biopsy + BXP154B/Left Leg Period 1; Punch Biopsy + Placebo/Right Leg Period 2 | Experimental | Drug: BXP154B, Drug: Placebo, Procedure: Punch BiopsySingle 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 |
| Punch Biopsy + Placebo/Left Leg Period 1; Punch Biopsy + BXP154B/Right Leg Period 2 | Experimental | Drug: BXP154B, Drug: Placebo, Procedure: Punch BiopsySingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXP154BBXP154B will be self-administered topically following wound induction | Drug | 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 |
| PlaceboPlacebo will be self-administered topically following wound induction | Drug | 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 BiopsyPunch biopsy to leg | Procedure or surgery | 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 |
Primary outcome
Time to achieve hemostasis (in minutes) following start of treatment
Time frame: 60 minutes following start of treatment
Time to achieve hemostasis (in minutes) will be compared between active treatment and control.
11 secondary outcomes
Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 40 mins, 50mins, 60mins
Time frame: 60 minutes following start of treatment
Proportion of subjects who require rescue treatment intervention to achieve hemostasis following biopsy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 72 hours following start of treatment
Proportion of subjects who experience rebleeding following initial hemostasis that requires subsequent medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment
Time frame: 72 hours following start of treatment
Number of rebleeding episodes following initial hemostasis that require subsequent medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment
Time frame: 72 hours following start of treatment
Time to achieve hemostasis (in minutes) following the start of treatment in subjects with a bleed time of at least 10 minutes in either treatment period
Time frame: 72 hours following start of treatment
Proportion of subjects who experience adverse events including adverse skin reactions and other clinically significant findings on physical exam; clinically significant lab values; and clinically significant changes in vital signs.
Time frame: 9 days
Systolic blood pressure
Time frame: 7 days
Diastolic blood pressure
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BXP154B and Punch Biopsy in people with Wound Bleeding, run by Bio 54, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve hemostasis (in minutes) following start of treatment (time frame: 60 minutes following start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.