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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio 54, LLC

Criteria

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 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