Wound BleedingPhase 2NCT05837338
Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
A Phase 2 study testing BXP154 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, 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… 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?
- BXP154
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 26 Jul 2023
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Accel Research Sites Network - DeLand
DeLand, Florida, 32720
About this study
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?
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 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
- Being tested
- BXP154, Placebo
- Keywords
- Anticoagulant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXP154Drug
BXP154 will be self-administered topically following wound induction
PlaceboDrug
Placebo will be self-administered topically following wound induction
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: BXP154; Drug: Placebo |
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 (13)
Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 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
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
Maximum plasma concentration (Cmax)
Cmax will be reported for individual subjects and summarized using descriptive statistics
Measured: 24 hours post dose
Time to reach Cmax (Tmax)
Tmax will be reported for individual subjects and summarized using descriptive statistics
Measured: 24 hours post dose
Area under the plasma concentration time curve (AUC)
AUC will be reported for individual subjects and summarized using descriptive statistics
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
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
- NCT05837338
- Sponsor's protocol ID
- BXP154-PIL
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2023
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
- ClinicalTrials.gov ID
- NCT05837338
- Acronym / sponsor ID
- BXP154-PIL
- 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
- 1 May 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 1 May 2023 (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, 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.
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 |
|---|---|---|
| Sequence A | Experimental | Drug: BXP154, Drug: PlaceboSingle topical application of BXP154 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2 |
| Sequence B | Experimental | Drug: BXP154, Drug: PlaceboSingle topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154 6ml (left leg), treatment period 2 |
| Sequence C | Experimental | Drug: BXP154, Drug: PlaceboSingle topical application of BXP154 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2 |
| Sequence D | Experimental | Drug: BXP154, Drug: PlaceboSingle topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154 6ml (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 (4 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 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| BXP154BXP154 will be self-administered topically following wound induction | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
| PlaceboPlacebo will be self-administered topically following wound induction | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
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.
13 secondary outcomes
Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 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
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
Maximum plasma concentration (Cmax)
Time frame: 24 hours post dose
Time to reach Cmax (Tmax)
Time frame: 24 hours post dose
Area under the plasma concentration time curve (AUC)
Time frame: 24 hours post dose
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 29 Jul 2024.
- 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 BXP154 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 4 inclusion and 8 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 29 Jul 2024. 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 29 Jul 2024.