A Phase 2 interventional study of BXP154 and Placebo in Wound Bleeding, sponsored by Bio 54, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Bio 54, LLC · Phase 2, Interventional, and Treatment
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:
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Bio 54, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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
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
BXP154 will be self-administered topically following wound induction
Placebo will be self-administered topically following wound induction
Time to achieve hemostasis (in minutes) following start of treatment
Time to achieve hemostasis (in minutes) will be compared between active treatment and control.
Time frame: 60 minutes following start of treatment
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.
Time frame: 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.
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 (in minutes) to achieve hemostasis will be compared between active treatment and control.
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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
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
Summarized as the proportion of subjects that met criteria and compared between active treatment and control.
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
Summarized as the number of episodes per subject compared between active treatment and control.
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.
Summarized as the proportion of subjects reporting adverse events compared between active treatment and control.
Time frame: 9 days
Systolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Time frame: 7 days
Diastolic blood pressure
Summarized as observed values and change from baseline compared between active treatment and control.
Time frame: 7 days
Maximum plasma concentration (Cmax)
Cmax will be reported for individual subjects and summarized using descriptive statistics
Time frame: 24 hours post dose
Time to reach Cmax (Tmax)
Tmax will be reported for individual subjects and summarized using descriptive statistics
Time frame: 24 hours post dose
Area under the plasma concentration time curve (AUC)
AUC will be reported for individual subjects and summarized using descriptive statistics
Time frame: 24 hours post dose
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Bio 54, LLC