Clinical trial NCT02074995: Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Official title: Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypercatabolic Status Related to Severe Burn
Keywords: Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Over 1 year
measure: Efficacy Measure by Change in Lean Body Mass (LBM)
timeFrame: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106
Secondary outcomes:
measure: Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: 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
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
measure: Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration
timeFrame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: