← Back to Search

BXP154B for Wound Bleeding

Phase 2

Recruiting

Research Sponsored by Bio 54, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours following start of treatment

Awards & highlights

Study Summary

This trial wants to see if the drug BXP154B can help stop bleeding in patients who are taking apixaban for blood thinning. They want to know how quickly the bleeding stops after using

Who is the study for?

This trial is for patients who are currently taking apixaban, an anticoagulant medication, and have experienced bleeding from a minor wound. Participants should be in need of treatment to stop the bleeding. Specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The study is testing BXP154B's effectiveness in stopping post-punch biopsy bleeding compared to a placebo. It will measure how quickly bleeding stops, if rescue treatments are needed, the rate of re-bleeding, and overall safety and tolerability of BXP154B.See study design

What are the potential side effects?

While specific side effects were not detailed, potential risks may include local reactions at the application site or systemic effects due to altering the blood clotting process; however, assessing safety and tolerability is one of this trial's objectives.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours following start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours following start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours following start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to achieve hemostasis (in minutes) following start of treatment

Secondary outcome measures

Diastolic blood pressure

Number of rebleeding episodes following initial hemostasis that require subsequent medical intervention to re-achieve hemostasis within 24, 48, and 72 hours after the start of treatment

Proportion of subjects who achieve hemostasis within 4mins, 8mins, 12mins, 16mins, 20mins, 25mins, 30mins, 40 mins, 50mins, 60mins

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Placebo/Right Leg Period 1; BXP154B/Left Leg Period 2Experimental Treatment2 Interventions

Single topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154B 6ml (left leg), treatment period 2

Group II: Placebo/Left Leg Period 1; BXP154B/Right Leg Period 2Experimental Treatment2 Interventions

Single topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154B 6ml (right leg), treatment period 2

Group III: BXP154B/Right Leg Period 1; Placebo/Left Leg Period 2Experimental Treatment2 Interventions

Single topical application of BXP154B 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2

Group IV: BXP154B/ Left Leg Period 1; Placebo/Right Leg Period 2Experimental Treatment2 Interventions

Single topical application of BXP154B 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bio 54, LLCLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

1 Trials studying Wound Bleeding

24 Patients Enrolled for Wound Bleeding

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing research study?

"My apologies for the confusion. According to clinicaltrials.gov, this particular study is not currently seeking participants. The trial was initially posted on January 15th, 2024 and last updated on January 4th, 2024. However, it's worth noting that there are presently 351 other studies actively accepting patients at this time."

Answered by AI

What are the potential health risks associated with Sequence A for individuals?

"Based on our assessment as the Power team, Sequence A is ranked 2 in terms of safety. This rating reflects that there is available data supporting safety but no evidence yet regarding efficacy since this trial falls under Phase 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B

2024. "Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205615.

All > Orlando > Tampa