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The study was prematurely terminated due to recruitment issues
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BVS857 Grp 1A open label | Experimental | 0.03 mg/kg of BVS857intravenously in open label manner |
|
| BVS857 Group 1B/1C, 2, 3, 4 Double Blind | Experimental |
| |
| Placebo Group 1B/1C, 2, 3, 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BVS857 | Biological | Group 1A&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Winston-Salem | North Carolina | 27157 | United States |
Not provided
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
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| ID | Title | Description |
|---|---|---|
| FG000 | BVS857 Grp 1A Open Label | 0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29. |
| FG001 | Placebo Group 1B/1C, 2, 3, 4 | |
| FG002 | BVS857 Group 1B/1C, 2, 3, 4 Double Blind |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BVS857 Grp 1A Open Label | 0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Participants | Over 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BVS857 Grp 1A Open Label | 0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| placebo | Other | Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses. |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Efficacy Measure by Change in Lean Body Mass (LBM) | Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan. | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| 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 | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| Secondary | Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration | Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided | Posted | Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105 |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |