Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Phase 2

Terminated

Conditions: Hypercatabolic Status Related to Severe Burn

Interventions: Biological: BVS857
Other: placebo

Registration Number: NCT02074995

Lead Sponsor: Novartis Pharmaceuticals

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

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVS857 Group 1B/1C, 2, 3, 4 Double Blind	BVS857	-
BVS857 Grp 1A open label	BVS857	0.03 mg/kg of BVS857intravenously in open label manner
Placebo Group 1B/1C, 2, 3, 4	placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	Over 1 year	Number of patients with adverse events as a measure of safety and tolerability
Efficacy Measure by Change in Lean Body Mass (LBM)	Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106	Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Name	Time	Method
Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life	Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration	Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105