Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154
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, 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?
Key facts
- Study ID
- NCT05837338
- Run by
- Bio 54, LLC
- People needed
- 24
- Starts
- 2023-05-01
- Expected to finish
- 2023-07-26
- Last updated by the study team
- 2024-07-29
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 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
You may not qualify if…
- 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
Where it is running
- Accel Research Sites Network - DeLand — DeLand, Florida, United States
Full record on ClinicalTrials.gov
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