Trial Outcomes & Findings for Safety and Efficacy Study in Infant With SBS (NCT NCT02865122)
NCT ID: NCT02865122
Last Updated: 2021-10-12
Results Overview
Percent change in %PN/IV from baseline based on caloric intake
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
2 participants
Primary outcome timeframe
baseline and end of treatment or 24 weeks, whichever occurs first
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
NTRA-9620-A
NTRA-9620 Dose 1: 2 IU/kg To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
NTRA-9620-B
NTRA-9620 Dose 2 - 1 IU/kg To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
Placebo
Placebo To be dosed orally for 24 weeks, 4 times/day
Placebo: Oral daily dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
NTRA-9620-A
NTRA-9620 Dose 1: 2 IU/kg To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
NTRA-9620-B
NTRA-9620 Dose 2 - 1 IU/kg To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
Placebo
Placebo To be dosed orally for 24 weeks, 4 times/day
Placebo: Oral daily dose
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study in Infant With SBS
Baseline characteristics by cohort
| Measure |
NTRA-9620-A
n=1 Participants
NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
NTRA-9620-B
n=1 Participants
NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
Placebo
Placebo To be dosed orally for 24 weeks, 4 times/day
Placebo: Oral daily dose
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and end of treatment or 24 weeks, whichever occurs firstPopulation: During the course of the study only two (2) subjects were enrolled prior to discontinuation. Thus, no conclusions regarding the efficacy or safety (risk/benefit) of NTRA-9620 in the short bowel syndrome (SBS) population can be determined from this study.
Percent change in %PN/IV from baseline based on caloric intake
Outcome measures
Outcome data not reported
Adverse Events
NTRA-9620-A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
NTRA-9620-B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NTRA-9620-A
n=1 participants at risk
NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
NTRA-9620-B
n=1 participants at risk
NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day
NTRA-9620: Oral daily dose
|
Placebo
Placebo To be dosed orally for 24 weeks, 4 times/day
Placebo: Oral daily dose
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
100.0%
1/1 • Number of events 5 • 6 months
Only one patient experienced Serious Adverse Events. There were no deaths in the study. There were no "Other" Adverse Events experienced in the study.
|
0.00%
0/1 • 6 months
Only one patient experienced Serious Adverse Events. There were no deaths in the study. There were no "Other" Adverse Events experienced in the study.
|
—
0/0 • 6 months
Only one patient experienced Serious Adverse Events. There were no deaths in the study. There were no "Other" Adverse Events experienced in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Miki Olshansky, Chief Executive Officer
Elgan Pharma Ltd.
Phone: 972-4-6098600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place