Pharmacokinetic Response to BPI in Burns

NCT00462904 | Terminated Phase 2 Results

• 1 other identifier: XO-400761
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of a protein called BPI that is naturally made by the body's white blood cells to fight infection.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Plasma Levels of BPI

  pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.

  48 hours of infusion and 24 hours post infusion

Secondary Outcomes (1)

• Safety Parameters

  28 days

Study Arms (1)

BPI infusion group

EXPERIMENTAL

BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours

Drug: BPI

Interventions

BPI DRUG

BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours

Also known as: Opebacan

BPI infusion group

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 13 years to 60 years old
• Sustained partial-thickness or full-thickness burn greater than 20% and less than 41% TBSA
• Parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent.
• Able to start BPI in infusion within 8 hours of burn injury.

You may not qualify if:

• Age \> 61.
• Inhalational injury requiring mechanical ventilation.
• Partial and full thickness burns totaling \> 41% total body surface area
• Cardiac dysfunction, defined as the presence of any of the following:
• New York Heart Class 3 or 4 heart failure.
• Unstable angina or acute myocardial infarction.
• Left ventricular ejection fraction known to be \< 35%.
• Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
• Concomitant non-burn trauma with an ISS \> 9.
• Non-survivable injury secondary to burn size - patients made DNR or comfort care due to burn size.
• Patients with known causes of immunosuppression:
• Known history of HIV/AIDS
• Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).
• Active oncolytic therapy for known malignancy
• Known or suspected pregnancy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9158, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Joseph Minei
• Organization: University of Texas Southwestern Medical Center

joseph.minei@utsouthwestern.edu

214-648-3917

Study Officials

• Joseph P Minei, MD

  UT Southwesten Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: April 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Locations

US (1)