Hypercatabolic Status Related to Severe Burn Clinical Trial
Official title:
Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
| Verified date | March 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Over 1 year | Yes |
| Primary | Efficacy Measure by Change in Lean Body Mass (LBM) | Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan. | Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106 | No |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |