Back to resultsPharmacokinetic Response to BPI in Burns
Primary Purpose
Burns
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BPI
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Known allergy to rBPI21
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BPI infusion group
Arm Description
BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours
Outcomes
Primary Outcome Measures
Plasma Levels of BPI
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Secondary Outcome Measures
Safety Parameters
Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function.
Full Information
NCT ID
NCT00462904
First Posted
April 17, 2007
Last Updated
October 31, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00462904
Brief Title
Pharmacokinetic Response to BPI in Burns
Official Title
Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Xoma to no longer supply drug for the study
Study Start Date
April 2006 (Actual)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study will initially evaluate an FDA approved investigational dosage and will measure the blood levels over time while BPI is being infused through a vein to see if the dose is potentially enough to obtain the desired effect. The drug will be started within 8 hours of burn injury and continued for 48 hours. Patients will be followed on admission and through infusion in the Burn ICU where they will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days 1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A blood sample will be obtained to look for potential genetic markers that may increase a burn patients' risk to develop infection in the post burn period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPI infusion group
Arm Type
Experimental
Arm Description
BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours
Intervention Type
Drug
Intervention Name(s)
BPI
Other Intervention Name(s)
Opebacan
Intervention Description
BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
Primary Outcome Measure Information:
Title
Plasma Levels of BPI
Description
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Time Frame
48 hours of infusion and 24 hours post infusion
Secondary Outcome Measure Information:
Title
Safety Parameters
Description
Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Known allergy to rBPI21
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Minei, MD
Organizational Affiliation
UT Southwesten Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9158
Country
United States
12. IPD Sharing Statement
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Pharmacokinetic Response to BPI in Burns
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