Status:
COMPLETED
Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B
Lead Sponsor:
Bio 54, LLC
Conditions:
Wound Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
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 ble...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06205615
Start Date
January 24 2024
End Date
March 18 2024
Last Update
March 18 2025
Active Locations (1)
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1
Accel Research Sites Network - DeLand
DeLand, Florida, United States, 32720