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Hemostatic Agent

Sequence A for Wound Bleeding

Phase 2

Waitlist Available

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 tests a drug to stop minor bleeding in people taking anticoagulants. It seeks to prove safety, efficacy and time to stop bleeding.

Eligible Conditions

Wound Bleeding

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

Area under the plasma concentration time curve (AUC)

Diastolic blood pressure

Maximum plasma concentration (Cmax)

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sequence DExperimental Treatment2 Interventions

Single topical application of Placebo 6ml (left leg), treatment period 1; single topical application of BXP154 6ml (right leg), treatment period 2

Group II: Sequence CExperimental Treatment2 Interventions

Single topical application of BXP154 6ml (left leg), treatment period 1; single topical application of Placebo 6ml (right leg), treatment period 2

Group III: Sequence BExperimental Treatment2 Interventions

Single topical application of Placebo 6ml (right leg), treatment period 1; single topical application of BXP154 6ml (left leg), treatment period 2

Group IV: Sequence AExperimental Treatment2 Interventions

Single topical application of BXP154 6ml (right leg), treatment period 1; single topical application of Placebo 6ml (left leg), treatment period 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BXP154

2023

Completed Phase 2

~30

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.

Has the FDA sanctioned Sequence B for use?

"Sequence B has been assigned a safety score of 2 as there is preliminary evidence that it's safe, but no efficacy data to back up the claim."

Answered by AI

Are there any available enrolment opportunities in this trial?

"Affirmative. Information hosted on clinicaltrials.gov reveals that this medical trial is still seeking participants, with the initial posting having been made in May 1st of 2023 and edited since then. This study requires 24 individuals to be recruited from one centre."

Answered by AI

How extensive is the participant base for this clinical trial?

"Affirmative, according to clinicaltrials.gov this study is actively recruiting participants. It was initially posted on May 1st 2023 and updated most recently on May 2nd 2023. The trial requires 24 individuals from a single medical centre to take part in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Treatment of Post-Punch Biopsy Bleeding in Anticoagulated Patients Using Self-Administered BXP154". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837338.