Trial Outcomes & Findings for Safety and Tolerability of Seroguard Use (NCT NCT03640559)
NCT ID: NCT03640559
Last Updated: 2019-05-03
Results Overview
Evaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter: * Vital signs (body temperature, BP, HR, RR) * Laboratory investigations: * Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine * Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR * Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT) * Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts * 12-channel ECG data - heart rate \[HR\], PR, QRS, QT intervals and calculated QTc interval * USG data * Incidence of adverse reactions * Incidence of serious adverse reactions
COMPLETED
PHASE1
50 participants
28 days
2019-05-03
Participant Flow
Participant milestones
| Measure |
Placebo
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of Seroguard Use
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
n=24 Participants
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
49.3 years
n=99 Participants
|
51.5 years
n=107 Participants
|
50.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
23 participants
n=99 Participants
|
24 participants
n=107 Participants
|
47 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 daysEvaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter: * Vital signs (body temperature, BP, HR, RR) * Laboratory investigations: * Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine * Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR * Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT) * Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts * 12-channel ECG data - heart rate \[HR\], PR, QRS, QT intervals and calculated QTc interval * USG data * Incidence of adverse reactions * Incidence of serious adverse reactions
Outcome measures
| Measure |
Placebo
n=23 Participants
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
n=24 Participants
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
16 Participants
|
17 Participants
|
Adverse Events
Placebo
Seroguard
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
n=24 participants at risk
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
|---|---|---|
|
Surgical and medical procedures
pains in the right supraclavicular area
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Leukocytosis
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Increased blood pressure up to 220/100 mm
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Misbirth
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Placebos
|
Seroguard
n=24 participants at risk
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Seroguard
|
|---|---|---|
|
Surgical and medical procedures
Hyperthermia
|
47.8%
11/23 • Number of events 24
|
50.0%
12/24 • Number of events 18
|
|
General disorders
Headache
|
26.1%
6/23 • Number of events 9
|
20.8%
5/24 • Number of events 16
|
|
Cardiac disorders
Arterial hypertension
|
4.3%
1/23 • Number of events 1
|
12.5%
3/24 • Number of events 7
|
|
General disorders
Pain in lower extremities
|
4.3%
1/23 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Back pain
|
0.00%
0/23
|
4.2%
1/24 • Number of events 2
|
|
Hepatobiliary disorders
Pain in the right hypochondrium
|
30.4%
7/23 • Number of events 10
|
12.5%
3/24 • Number of events 9
|
|
Infections and infestations
Sore throat
|
0.00%
0/23
|
12.5%
3/24 • Number of events 3
|
|
Surgical and medical procedures
Pain in right side of chest
|
8.7%
2/23 • Number of events 2
|
0.00%
0/24
|
|
Gastrointestinal disorders
Epigastric pain
|
21.7%
5/23 • Number of events 7
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 3
|
4.2%
1/24 • Number of events 3
|
|
Surgical and medical procedures
Pain in postoperative wound
|
13.0%
3/23 • Number of events 3
|
0.00%
0/24
|
|
Renal and urinary disorders
Kidney pain
|
4.3%
1/23 • Number of events 2
|
0.00%
0/24
|
|
Surgical and medical procedures
Pain in the right infraclavicular region
|
13.0%
3/23 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Hypertensive crisis
|
0.00%
0/23
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Dizziness
|
4.3%
1/23 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 6
|
8.3%
2/24 • Number of events 3
|
|
General disorders
Toothache
|
0.00%
0/23
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Burning sensation
|
0.00%
0/23
|
12.5%
3/24 • Number of events 8
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/23
|
4.2%
1/24 • Number of events 2
|
|
Gastrointestinal disorders
Cholemesis
|
8.7%
2/23 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Palpitation
|
0.00%
0/23
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Weakness
|
4.3%
1/23 • Number of events 2
|
12.5%
3/24 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 3
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Heaviness in epigastrium
|
13.0%
3/23 • Number of events 6
|
8.3%
2/24 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place