Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154 (NCT05837338) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
Time to achieve hemostasis (in minutes) following start of treatment
Timeframe: 60 minutes following start of treatment