CompletedPhase 2

Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154

United States24 participantsStarted 2023-05-01

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 NSAID…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to achieve hemostasis (in minutes) following start of treatment

Timeframe: 60 minutes following start of treatment

Trial details

NCT IDNCT05837338

SponsorBio 54, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-26

View on ClinicalTrials.gov More Wound Bleeding trials