BurnsPhase 2NCT00462904
Pharmacokinetic Response to BPI in Burns
A Phase 2 study testing BPI in people with Burns, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- BPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9158
About this study
Official title: Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.
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.
Read the 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.
- Conditions
- Burns
- Being tested
- BPI
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPIDrug
Also called Opebacan
BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
| Study group | Role | What they receive |
|---|---|---|
| BPI infusion group | Experimental | BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours Receives: Drug: BPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Levels of BPI
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Measured: 48 hours of infusion and 24 hours post infusion
Secondary outcomes (1)
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startApr 2006
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Xoma to no longer supply drug for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph P. Minei, University of Texas Southwestern Medical Center
- Investigators
- Joseph P Minei, MD, Principal investigator, UT Southwesten Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462904
- Sponsor's protocol ID
- XO-400761
- Status last verified
- Oct 2019
- First submitted
- 17 Apr 2007
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.
- ClinicalTrials.gov ID
- NCT00462904
- Acronym / sponsor ID
- XO-400761
- Conditions
- Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Xoma to no longer supply drug for the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Apr 2006 (actual)
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPI infusion group | Experimental | Drug: BPIBPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPIAlso: OpebacanBPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours | Drug | BPI infusion group |
Primary outcome
Plasma Levels of BPI
Time frame: 48 hours of infusion and 24 hours post infusion
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
1 secondary outcome
Safety Parameters
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Minei, MD principal investigator
UT Southwesten Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPI in people with Burns, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Levels of BPI (time frame: 48 hours of infusion and 24 hours post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.