Trial Outcomes & Findings for Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects (NCT NCT02074995)
NCT ID: NCT02074995
Last Updated: 2016-03-07
Results Overview
Number of patients with adverse events as a measure of safety and tolerability
TERMINATED
PHASE2
1 participants
Over 1 year
2016-03-07
Participant Flow
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
Participant milestones
| Measure |
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.
|
Placebo Group 1B/1C, 2, 3, 4
|
BVS857 Group 1B/1C, 2, 3, 4 Double Blind
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Baseline characteristics by cohort
| Measure |
BVS857 Grp 1A Open Label
n=1 Participants
0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Over 1 yearNumber of patients with adverse events as a measure of safety and tolerability
Outcome measures
| Measure |
BVS857 Grp 1A Open Label
n=1 Participants
0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
|
|---|---|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Adverse Events
|
1 Participants
|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Serious Adverse Events
|
0 Participants
|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Death
|
0 Participants
|
PRIMARY outcome
Timeframe: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105Population: Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided
Outcome measures
Outcome data not reported
Adverse Events
BVS857 Grp 1A Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BVS857 Grp 1A Open Label
n=1 participants at risk
0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
|
|---|---|
|
Infections and infestations
bacteremia
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER