Trial Outcomes & Findings for Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148 (NCT NCT02317549)
NCT ID: NCT02317549
Last Updated: 2020-06-01
Results Overview
The patient will be classified as having organ support if organ support is required through the use of: * Mechanical ventilation; * Vasopressors to maintain adequate blood pressure (BP), or * Renal replacement therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Through day 28.
Results posted on
2020-06-01
Participant Flow
Participants took part in the study from 6 sites in the US and Canada from 22 January 2015 to 18 March 2016 (day FDA was informed of decision to terminate the study).
The Sponsor decided to terminate this study due to slow enrollment. Throughout the study, the Sponsor made 4 protocol amendments in an effort to expand the inclusion and relax the exclusion criteria to accelerate patient enrollment. However, study was terminated after enrolling only 8 patients.
Participant milestones
| Measure |
Tranexemic Acid
Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube
LB1148
|
Placebo
Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age not collected for one patient.
Baseline characteristics by cohort
| Measure |
Tranexemic Acid
n=5 Participants
Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube
LB1148
|
Placebo
n=3 Participants
Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube
Placebo
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants • Age not collected for one patient.
|
0 Participants
n=3 Participants • Age not collected for one patient.
|
0 Participants
n=7 Participants • Age not collected for one patient.
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants • Age not collected for one patient.
|
1 Participants
n=3 Participants • Age not collected for one patient.
|
4 Participants
n=7 Participants • Age not collected for one patient.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants • Age not collected for one patient.
|
2 Participants
n=3 Participants • Age not collected for one patient.
|
3 Participants
n=7 Participants • Age not collected for one patient.
|
|
Age, Continuous
|
50.59 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
63.75 years
STANDARD_DEVIATION 2.26 • n=3 Participants
|
56.23 years
STANDARD_DEVIATION 12.07 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
|
Weight
|
82.76 kg
STANDARD_DEVIATION 21.11 • n=5 Participants
|
80.67 kg
STANDARD_DEVIATION 13.96 • n=3 Participants
|
81.98 kg
STANDARD_DEVIATION 17.65 • n=8 Participants
|
|
Height
|
169 cm
STANDARD_DEVIATION 13.49 • n=5 Participants
|
157 cm
STANDARD_DEVIATION 6.08 • n=3 Participants
|
164.5 cm
STANDARD_DEVIATION 12.38 • n=8 Participants
|
|
BMI
|
28.96 kg/m^2
STANDARD_DEVIATION 7.21 • n=5 Participants
|
32.54 kg/m^2
STANDARD_DEVIATION 3.45 • n=3 Participants
|
30.30 kg/m^2
STANDARD_DEVIATION 6.05 • n=8 Participants
|
|
SOFA Distribution at Screening
Highest Score = 6-8
|
0 units on a scale
n=5 Participants
|
1 units on a scale
n=3 Participants
|
1 units on a scale
n=8 Participants
|
|
SOFA Distribution at Screening
Highest Score = 9-11
|
3 units on a scale
n=5 Participants
|
2 units on a scale
n=3 Participants
|
5 units on a scale
n=8 Participants
|
|
SOFA Distribution at Screening
Highest Score = 12-14
|
2 units on a scale
n=5 Participants
|
0 units on a scale
n=3 Participants
|
2 units on a scale
n=8 Participants
|
|
SOFA Distribution at Screening
Highest Score = 15-18
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=3 Participants
|
0 units on a scale
n=8 Participants
|
PRIMARY outcome
Timeframe: Through day 28.Population: 5 subjects were treated with LB1148, and 3 subjects were treated with placebo. Upon review of patient charts after the study was terminated, 1 patient on placebo was enrolled on the basis of a Glasgow Coma Score calculated while under sedation, which allowed SOFA score to meet study criteria and the patient to be inappropriately enrolled.
The patient will be classified as having organ support if organ support is required through the use of: * Mechanical ventilation; * Vasopressors to maintain adequate blood pressure (BP), or * Renal replacement therapy.
Outcome measures
| Measure |
Tranexemic Acid
n=5 Participants
Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube
LB1148
|
Placebo
n=3 Participants
Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube
Placebo
|
|---|---|---|
|
Number of Days Alive Without Cardiovascular, Renal or Pulmonary Organ Support
|
14 days
Interval 0.0 to 23.0
|
26 days
Interval 26.0 to 27.0
|
Adverse Events
Tranexemic Acid
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexemic Acid
n=5 participants at risk
Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube
LB1148
|
Placebo
n=3 participants at risk
Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube
Placebo
|
|---|---|---|
|
Infections and infestations
Worsening Gangrene
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac Arrest
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Malnutrition Status Post Dobhoff feeding tube removal
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Refractory Septic Shock (Death)
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Tranexemic Acid
n=5 participants at risk
Daily a total of 700 mL of LB1148 solution containing 7.5 g of tranexemic acid will be administered orally or via NG/OG/NJ/ND/PEG tube
LB1148
|
Placebo
n=3 participants at risk
Daily a total of 700 mL of Placebo solution will be administered orally or via NG/OG/NJ/ND/PEG tube
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Difficulty Swallowing
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Elevated AST
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Fluid Overload
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Fungal skin rash (groin and scrotum)
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Hypothermia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Increase in total bilirubin above lab range for normal
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Injury, poisoning and procedural complications
Left Wrist Abrasion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pedal Edema
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Possible ileus with distention and hypoactive bowel sounds
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pressure Ulcer Left Buttock
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Right Hand Redness
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
SVT (15 beat run)
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Ventricular Tachycardia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Worsening Anemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Worsening Pneumonia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Renal and urinary disorders
Worsening Renal Failure
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place