Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement (NCT NCT03812328)
NCT ID: NCT03812328
Last Updated: 2021-01-06
Results Overview
The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
207 participants
Primary outcome timeframe
10 ± 2 Days After Total Knee Replacement
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
SelK2
I.V., single-dose
|
SelK2 and Enoxaparin
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
|
Enoxaparin
QD for up to 10 ± 2 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
63
|
89
|
|
Overall Study
Modified Intent-to-Treat (mITT) Population
|
48
|
61
|
84
|
|
Overall Study
Safety Population
|
55
|
63
|
88
|
|
Overall Study
COMPLETED
|
55
|
60
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Baseline characteristics by cohort
| Measure |
SelK2
n=55 Participants
I.V., single-dose
|
SelK2 and Enoxaparin
n=63 Participants
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
SelK2: I.V., single-dose
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Enoxaparin
n=89 Participants
SC, QD for up to 10 ± 2 days
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Total
n=207 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 6.35 • n=99 Participants
|
66.3 years
STANDARD_DEVIATION 7.54 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 7.30 • n=206 Participants
|
66.0 years
STANDARD_DEVIATION 7.11 • n=7 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
162 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
205 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Latvia
|
15 participants
n=99 Participants
|
27 participants
n=107 Participants
|
30 participants
n=206 Participants
|
72 participants
n=7 Participants
|
|
Region of Enrollment
Ukraine
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
27 participants
n=206 Participants
|
61 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
11 participants
n=99 Participants
|
1 participants
n=107 Participants
|
10 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Region of Enrollment
Lithuania
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
18 participants
n=206 Participants
|
44 participants
n=7 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 10 ± 2 Days After Total Knee ReplacementPopulation: Analysis was performed on the modified intent-to-treat (mITT) population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome.
The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).
Outcome measures
| Measure |
SelK2
n=48 Participants
I.V., single-dose
|
SelK2 and Enoxaparin
n=61 Participants
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
SelK2: I.V., single-dose
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Enoxaparin
n=84 Participants
SC, QD for up to 10 ± 2 days
Enoxaparin: SC, QD for up to 10 ± 2 days
|
|---|---|---|---|
|
Percentage of Participants With Total Venous Thromboembolism
|
19 Participants
|
29 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 10 ± 2 Days After Total Knee ReplacementPopulation: Analysis was performed on the safety population consisting of all patients who received at least 1 dose of study drug, analyzed by actual treatment received.
All suspected bleeding events were reviewed by the Central Independent Adjudication Committee (CIAC) in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The outcome measure assessed the incidence of MB or CRNMB.
Outcome measures
| Measure |
SelK2
n=55 Participants
I.V., single-dose
|
SelK2 and Enoxaparin
n=63 Participants
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
SelK2: I.V., single-dose
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Enoxaparin
n=88 Participants
SC, QD for up to 10 ± 2 days
Enoxaparin: SC, QD for up to 10 ± 2 days
|
|---|---|---|---|
|
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
|
2 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
SelK2
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
SelK2 and Enoxaparin
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Enoxaparin
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SelK2
n=55 participants at risk
I.V., single-dose
|
SelK2 and Enoxaparin
n=63 participants at risk
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
SelK2: I.V., single-dose
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Enoxaparin
n=88 participants at risk
SC, QD for up to 10 ± 2 days
Enoxaparin: SC, QD for up to 10 ± 2 days
|
|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/55 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
1.1%
1/88 • Number of events 1 • Through Day 57
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/55 • Through Day 57
|
1.6%
1/63 • Number of events 1 • Through Day 57
|
0.00%
0/88 • Through Day 57
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
1/55 • Number of events 1 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
0.00%
0/88 • Through Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/55 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
1.1%
1/88 • Number of events 1 • Through Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
1/55 • Number of events 1 • Through Day 57
|
1.6%
1/63 • Number of events 1 • Through Day 57
|
0.00%
0/88 • Through Day 57
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/55 • Through Day 57
|
1.6%
1/63 • Number of events 1 • Through Day 57
|
0.00%
0/88 • Through Day 57
|
Other adverse events
| Measure |
SelK2
n=55 participants at risk
I.V., single-dose
|
SelK2 and Enoxaparin
n=63 participants at risk
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
SelK2: I.V., single-dose
Enoxaparin: SC, QD for up to 10 ± 2 days
|
Enoxaparin
n=88 participants at risk
SC, QD for up to 10 ± 2 days
Enoxaparin: SC, QD for up to 10 ± 2 days
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.5%
3/55 • Number of events 3 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
1.1%
1/88 • Number of events 1 • Through Day 57
|
|
Vascular disorders
Deep vein thrombosis
|
3.6%
2/55 • Number of events 2 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
2.3%
2/88 • Number of events 2 • Through Day 57
|
|
Vascular disorders
Hypertension
|
3.6%
2/55 • Number of events 2 • Through Day 57
|
0.00%
0/63 • Through Day 57
|
1.1%
1/88 • Number of events 1 • Through Day 57
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55 • Through Day 57
|
1.6%
1/63 • Number of events 1 • Through Day 57
|
2.3%
2/88 • Number of events 2 • Through Day 57
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/55 • Through Day 57
|
3.2%
2/63 • Number of events 2 • Through Day 57
|
1.1%
1/88 • Number of events 1 • Through Day 57
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.5%
3/55 • Number of events 3 • Through Day 57
|
6.3%
4/63 • Number of events 4 • Through Day 57
|
6.8%
6/88 • Number of events 6 • Through Day 57
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
2/55 • Number of events 2 • Through Day 57
|
1.6%
1/63 • Number of events 1 • Through Day 57
|
0.00%
0/88 • Through Day 57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60