Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypercatabolic Status Related to Severe Burn

In brief

Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks

Key facts

Study ID

NCT02074995

Run by

Novartis Pharmaceuticals

People needed

1

Starts

2014-02-01

Expected to finish

2015-01-01

Last updated by the study team

2016-03-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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