Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hypercatabolic Status Related to Severe Burn

Treatments: Other: placebo; Biological: BVS857

Study type: Interventional

Funder types: Industry

Identifiers

NCT02074995

CBVS857X2201

Details and patient eligibility

About

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

Full description

No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)

Enrollment: 1 patient

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 3 patient groups, including a placebo group

BVS857 Grp 1A open label

Experimental group

Description:

0.03 mg/kg of BVS857intravenously in open label manner

Treatment:

Biological: BVS857

BVS857 Group 1B/1C, 2, 3, 4 Double Blind

Experimental group

Treatment:

Biological: BVS857

Placebo Group 1B/1C, 2, 3, 4

Placebo Comparator group

Treatment:

Other: placebo