Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Phase 2TerminatedNCT02074995

Novartis Pharmaceuticals1 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypercatabolic Status Related to Severe Burn

Interventions

BVS857BIOLOGICAL

Group 1A\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.

placeboOTHER

Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Number of Patients With Adverse Events as a Measure of Safety and Tolerability

Number of patients with adverse events as a measure of safety and tolerability

Time frame: Over 1 year

Efficacy Measure by Change in Lean Body Mass (LBM)

Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.

Time frame: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106

Secondary Outcomes

Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration

Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105

Data from ClinicalTrials.gov

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