Wound Bleeding
Conditions
Keywords
Anticoagulant
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.
Interventions
DRUGBXP154
BXP154 will be self-administered topically following wound induction
DRUGPlacebo
Placebo will be self-administered topically following wound induction
Sponsors
Bio 54, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled, 2-way crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve hemostasis (in minutes) following start of treatment | 60 minutes following start of treatment | Time to achieve hemostasis (in minutes) will be compared between active treatment and control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who require rescue treatment intervention to achieve hemostasis following biopsy | 60 minutes following start of treatment | 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 | 72 hours following 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 | 72 hours following 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 | 72 hours following 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 | 72 hours following 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 | 72 hours following start of treatment | Summarized as the number of episodes per subject compared between active treatment and control. |
| Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 50mins, 60mins | 60 minutes following start of treatment | Summarized as the proportion of subjects that met criteria and compared between active treatment and control. |
| Systolic blood pressure | 7 days | Summarized as observed values and change from baseline compared between active treatment and control. |
| Diastolic blood pressure | 7 days | Summarized as observed values and change from baseline compared between active treatment and control. |
| Maximum plasma concentration (Cmax) | 24 hours post dose | Cmax will be reported for individual subjects and summarized using descriptive statistics |
| Time to reach Cmax (Tmax) | 24 hours post dose | Tmax will be reported for individual subjects and summarized using descriptive statistics |
| Area under the plasma concentration time curve (AUC) | 24 hours post dose | AUC will be reported for individual subjects and summarized using descriptive statistics |
| 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. | 9 days | Summarized as the proportion of subjects reporting adverse events compared between active treatment and control. |
Countries
United States
Outcome results
None listed