Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205615
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-01-04
Brief Title:
Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B
Sponsor:
Bio 54 LLC
Organization:
Bio 54 LLC
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled 2-Way Crossover Study to Evaluate the Efficacy and Safety of BXP154B Tranexamic Acid Sterile Topical Solution in the Treatment of External Bleeding From Minor Wounds in Subjects on Apixaban
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Oral anticoagulant-related clinically relevant nonmajor bleeding CRNMB ie non-major bleeding that requires medical intervention increased level of care or face-to-face evaluation and minor bleeding often referred to as nuisance bleeding carries a high burden in terms of patient discomfort anxiety temporary disability and reduced quality of life and strain on medical and socioeconomic resources Prolonged bleeding following minor injuries falls scrapes cuts can be life-interrupting and frequently leads patients to seek medical care often times in an urgent care or emergency department ED setting Prolonged bleeding from minor injuries is a significant challenge to daily life for people on anticoagulants and is anything but minor to the patient
Bio 54 LLC is developing BXP154B a topical agent intended for self-administration in or outside the home to treat external bleeding from minor wounds in patients on anticoagulants The development of BXP154B will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home
BXP154-201 is a randomized double-blind placebo-controlled 2-way crossover-design study to evaluate the efficacy and safety of BXP154 6 mL compared with volume-matched placebo in the treatment of bleeding following punch biopsy in subjects on apixaban
Subjects will be enrolled in this clinical trial for a total of seven days following a screening period of up to 28 days The study commences on Day 1 with a skin punch biopsy and administration of the investigational drug or placebo Subsequently follow-up assessments will be conducted on Days 2 3 and 4 A second skin punch biopsy will be performed on Day 4 followed by additional follow-up assessments on Days 5 6 and 7 Upon completion of the Day 7 assessments subjects will have fulfilled their involvement in the study
Bio 54 LLC is developing BXP154B a topical agent intended for self-administration in or outside the home to treat external bleeding from minor wounds in patients on anticoagulants The development of BXP154B will offer patients on anticoagulants a much-needed treatment for self-management of external bleeding from minor wounds at home
BXP154-201 is a randomized double-blind placebo-controlled 2-way crossover-design study to evaluate the efficacy and safety of BXP154 6 mL compared with volume-matched placebo in the treatment of bleeding following punch biopsy in subjects on apixaban
Subjects will be enrolled in this clinical trial for a total of seven days following a screening period of up to 28 days The study commences on Day 1 with a skin punch biopsy and administration of the investigational drug or placebo Subsequently follow-up assessments will be conducted on Days 2 3 and 4 A second skin punch biopsy will be performed on Day 4 followed by additional follow-up assessments on Days 5 6 and 7 Upon completion of the Day 7 assessments subjects will have fulfilled their involvement in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None