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Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Primary Purpose

Hypercatabolic Status Related to Severe Burn

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BVS857
placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercatabolic Status Related to Severe Burn focused on measuring Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BVS857 Grp 1A open label

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

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

Arm Description

0.03 mg/kg of BVS857intravenously in open label manner

Outcomes

Primary Outcome Measures

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
Efficacy Measure by Change in Lean Body Mass (LBM)
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration
Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration
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
Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity
Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life
Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration
Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration
Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration
Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration
Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration

Full Information

First Posted
February 27, 2014
Last Updated
March 3, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02074995
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated due to recruitment issues
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercatabolic Status Related to Severe Burn
Keywords
Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BVS857 Grp 1A open label
Arm Type
Experimental
Arm Description
0.03 mg/kg of BVS857intravenously in open label manner
Arm Title
BVS857 Group 1B/1C, 2, 3, 4 Double Blind
Arm Type
Experimental
Arm Title
Placebo Group 1B/1C, 2, 3, 4
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
BVS857
Intervention Description
Group 1A&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Description
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
Over 1 year
Title
Efficacy Measure by Change in Lean Body Mass (LBM)
Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration
Time Frame
Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Title
Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration
Time Frame
Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Title
Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration
Time Frame
Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Title
Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration
Time Frame
Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Title
Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration
Time Frame
Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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