A Phase 2 interventional study of BVS857 and placebo in Hypercatabolic Status Related to Severe Burn, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-03-07.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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)
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.03 mg/kg of BVS857intravenously in open label manner
Biological: BVS857
Biological: BVS857
Other: placebo
Group 1A\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
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
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
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
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
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
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
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
The study was planned to have 4 groups of patients. In Group 1: the bioavailability of BVS857 following subcutaneous administration was planned. Groups 2-4 (Group 4 optional) different BVS857 doses were planned for safety, PK and efficacy assessments. Study was terminated due to low enrollment as only 1 patient was enrolled
| Milestone | BVS857 Grp 1A Open Label | Placebo Group 1B/1C, 2, 3, 4 | BVS857 Group 1B/1C, 2, 3, 4 Double Blind |
|---|---|---|---|
| Started | 1 | 0 | 0 |
| Completed | 1 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
Number of patients with adverse events as a measure of safety and tolerability
| Participants | BVS857 Grp 1A Open Label |
|---|---|
| Adverse Events | 1 |
| Serious Adverse Events | 0 |
| Death | 0 |
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BVS857 Grp 1A Open Label | — | 0/1 (0%) | 1/1 (100%) |
| Event | BVS857 Grp 1A Open Label |
|---|---|
| bacteremiaInfections and infestations | 1/1 |
| Age, Categorical(Participants) | BVS857 Grp 1A Open Label |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | BVS857 Grp 1A Open Label |
|---|---|
| Female | 0 |
| Male | 1 |
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals