Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B
Completed · Phase 2 · Has a placebo group
Conditions studied: Wound Bleeding
In brief
The goal of this clinical trial is to test if the study drug, BXP154B works to stop bleeding from a minor wound in patients that are on apixaban for anticoagulant therapy. The main questions it aims to answer are: * How long does it take to stop bleeding after BXP154B is applied to a wound? * How many people require the use of a rescue treatment to stop bleeding? * Does BXP154B reduce instances of re-bleeding after the bleeding has stopped initially? * Is BXP154B safe and well-tolerated?
Key facts
- Study ID
- NCT06205615
- Run by
- Bio 54, LLC
- People needed
- 24
- Starts
- 2024-01-24
- Expected to finish
- 2024-03-18
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 apixaban (Eliquis®) and on a BID dosing regimen 5 mg BID (10 mg total daily dose). Subjects must have been on the same dosing regimen for at least 7 days prior to Day 1.
- Willing and able to provide informed consent prior to any study procedures and to comply with all aspects of the protocol
You may not qualify if…
- Allergy or sensitization to any components of BXP154B
- BMI ≥ 50 kg/m2
- 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.
- Use of any other anticoagulant therapies other than apixaban 5mg BID
- 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. In addition, subjects who participated in BXP154-PIL are not eligible for this study.
- Any clinically significant finding on screening assessments or other physical or neurological condition that, in the opinion of the investigator, impairs the ability of the subject to comply with protocol procedures and safely participate in the study
Where it is running
- Accel Research Sites Network - DeLand — DeLand, Florida, United States
Full record on ClinicalTrials.gov
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