Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects (NCT02074995) | Clinical Trial Compass
TerminatedPhase 2
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Stopped: The study was prematurely terminated due to recruitment issues
United States1 participantsStarted 2014-02
Plain-language summary
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
* Dosing must occur within 8-12 days post-burn
* Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study
Exclusion Criteria:
* Spinal cord injury
* Hypoxic brain injury (Glasgow Coma Scale (GCS) \<8) at screening
* True conductive electric burn with suspected neurologic injury
* Uncontrolled diabetes with HbA1c \> 10% at screening, or known history of hypoglycemia,
* History of or active peripheral neuropathy or seizure disorder
* Systemic corticosteroids : \> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Timeframe: Over 1 year
2
Efficacy Measure by Change in Lean Body Mass (LBM)
Timeframe: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106