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 range18 Years – 60 Years
SexALL
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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
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