Back to resultsTreatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
Primary Purpose
Wound Bleeding
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BXP154
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wound Bleeding focused on measuring Anticoagulant
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Accel Research Sites Network - DeLand
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Sequence C
Sequence D
Arm Description
Single topical application of BXP154 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2
Single topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154 6ml (left leg), treatment period 2
Single topical application of BXP154 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2
Single topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154 6ml (right leg), treatment period 2
Outcomes
Primary Outcome Measures
Time to achieve hemostasis (in minutes) following start of treatment
Time to achieve hemostasis (in minutes) will be compared between active treatment and control.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Systolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Diastolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Maximum plasma concentration (Cmax)
Cmax will be reported for individual subjects and summarized using descriptive statistics
Time to reach Cmax (Tmax)
Tmax will be reported for individual subjects and summarized using descriptive statistics
Area under the plasma concentration time curve (AUC)
AUC will be reported for individual subjects and summarized using descriptive statistics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05837338
Brief Title
Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
Official Title
Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 26, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio 54, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Bleeding
Keywords
Anticoagulant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, placebo-controlled, 2-way crossover
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Single topical application of BXP154 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Single topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154 6ml (left leg), treatment period 2
Arm Title
Sequence C
Arm Type
Experimental
Arm Description
Single topical application of BXP154 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2
Arm Title
Sequence D
Arm Type
Experimental
Arm Description
Single topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154 6ml (right leg), treatment period 2
Intervention Type
Drug
Intervention Name(s)
BXP154
Intervention Description
BXP154 will be self-administered topically following wound induction
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be self-administered topically following wound induction
Primary Outcome Measure Information:
Title
Time to achieve hemostasis (in minutes) following start of treatment
Description
Time to achieve hemostasis (in minutes) will be compared between active treatment and control.
Time Frame
60 minutes following start of treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 50mins, 60mins
Description
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Time Frame
60 minutes following start of treatment
Title
Proportion of subjects who require rescue treatment intervention to achieve hemostasis following biopsy
Description
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Time Frame
60 minutes following start of treatment
Title
Time to achieve hemostasis (in minutes) with no rebleeding requiring self-managed or medical intervention within 72 hours after the start of treatment
Description
Time (in minutes) to achieve hemostasis will be compared between active treatment and control.
Time Frame
72 hours following start of treatment
Title
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
Description
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Time Frame
72 hours following start of treatment
Title
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
Description
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Time Frame
72 hours following start of treatment
Title
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
Description
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
Time Frame
72 hours following start of treatment
Title
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
Description
Summarized as the number of episodes per subject compared between active treatment and control.
Time Frame
72 hours following start of treatment
Title
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.
Description
Summarized as the proportion of subjects reporting adverse events compared between active treatment and control.
Time Frame
9 days
Title
Systolic blood pressure
Description
Summarized as observed values and change from baseline compared between active treatment and control.
Time Frame
7 days
Title
Diastolic blood pressure
Description
Summarized as observed values and change from baseline compared between active treatment and control.
Time Frame
7 days
Title
Maximum plasma concentration (Cmax)
Description
Cmax will be reported for individual subjects and summarized using descriptive statistics
Time Frame
24 hours post dose
Title
Time to reach Cmax (Tmax)
Description
Tmax will be reported for individual subjects and summarized using descriptive statistics
Time Frame
24 hours post dose
Title
Area under the plasma concentration time curve (AUC)
Description
AUC will be reported for individual subjects and summarized using descriptive statistics
Time Frame
24 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Accel Research Sites Network - DeLand
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
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