Trial Outcomes & Findings for Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (NCT NCT00938314)
NCT ID: NCT00938314
Last Updated: 2011-11-29
Results Overview
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline and Day 90
Results posted on
2011-11-29
Participant Flow
Participant milestones
| Measure |
NTx®-265 Low Dose
human chorionic gonadotropin (hCG) 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Placebo
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Cohort 1
STARTED
|
24
|
0
|
0
|
8
|
|
Cohort 1
COMPLETED
|
22
|
0
|
0
|
6
|
|
Cohort 1
NOT COMPLETED
|
2
|
0
|
0
|
2
|
|
Cohort 2
STARTED
|
0
|
24
|
0
|
8
|
|
Cohort 2
COMPLETED
|
0
|
18
|
0
|
6
|
|
Cohort 2
NOT COMPLETED
|
0
|
6
|
0
|
2
|
|
Cohort 3
STARTED
|
0
|
0
|
24
|
8
|
|
Cohort 3
COMPLETED
|
0
|
0
|
20
|
7
|
|
Cohort 3
NOT COMPLETED
|
0
|
0
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Baseline characteristics by cohort
| Measure |
NTx®-265 Low Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
67 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Age Continuous
|
57.42 years
STANDARD_DEVIATION 10.49 • n=93 Participants
|
58.58 years
STANDARD_DEVIATION 13.32 • n=4 Participants
|
54.83 years
STANDARD_DEVIATION 12.98 • n=27 Participants
|
61.67 years
STANDARD_DEVIATION 12.38 • n=483 Participants
|
58.13 years
STANDARD_DEVIATION 12.39 • n=36 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
65 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Region of Enrollment
India
|
24 participants
n=93 Participants
|
22 participants
n=4 Participants
|
24 participants
n=27 Participants
|
24 participants
n=483 Participants
|
94 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 90Population: The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
Outcome measures
| Measure |
NTx®-265 Low Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
|
6.79 scores on a scale
Standard Deviation 4.22
|
6.50 scores on a scale
Standard Deviation 4.53
|
6.08 scores on a scale
Standard Deviation 3.30
|
7.17 scores on a scale
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response \>=4 is defined as a \>=4 change from baseline at Day 90.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
NIHSS Response >=4 at Day 90
No Response (<4)
|
6 participants
|
7 participants
|
5 participants
|
5 participants
|
|
NIHSS Response >=4 at Day 90
Response (>=4)
|
18 participants
|
17 participants
|
19 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 30Population: The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
Outcome measures
| Measure |
NTx®-265 Low Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
NIHSS Change From Baseline at Day 30
|
4.67 scores on a scale
Standard Deviation 4.53
|
4.29 scores on a scale
Standard Deviation 3.37
|
5.00 scores on a scale
Standard Deviation 2.98
|
5.33 scores on a scale
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Day 90Population: The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response \<=2 is defined as the mRS score \<=2 at Day 90.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Modified Rankin Scale (mRS) Response <=2 at Day 90
response (mRS <=2)
|
11 participants
|
11 participants
|
15 participants
|
18 participants
|
|
Modified Rankin Scale (mRS) Response <=2 at Day 90
No response (mRS > 2)
|
13 participants
|
13 participants
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 90Population: The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=22 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=18 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=20 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=19 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Barthel Index at Day 90
|
68.18 Scores on a scale
Standard Deviation 29.62
|
80.17 Scores on a scale
Standard Deviation 22.04
|
85.25 Scores on a scale
Standard Deviation 20.28
|
90.89 Scores on a scale
Standard Deviation 12.69
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=6 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=6 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=3 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=4 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Action Research Arm Test (ARAT) Change From Baseline at Day 90
|
10.67 scores on a scale
Standard Deviation 13.37
|
33.50 scores on a scale
Standard Deviation 26.12
|
30.33 scores on a scale
Standard Deviation 16.80
|
23.75 scores on a scale
Standard Deviation 20.27
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=4 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=3 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=5 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=5 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Gait Velocity Test Change From Baseline at Day 90
|
-22.75 seconds
Standard Deviation 41.60
|
-50.33 seconds
Standard Deviation 48.95
|
-6.40 seconds
Standard Deviation 7.37
|
-53.80 seconds
Standard Deviation 54.15
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=14 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=12 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=10 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=13 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Boston Naming Test (BNT) Change From Baseline at Day 90
|
3.93 Scores on a scale
Standard Deviation 3.10
|
4.17 Scores on a scale
Standard Deviation 4.11
|
0.20 Scores on a scale
Standard Deviation 2.74
|
3.69 Scores on a scale
Standard Deviation 3.82
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=7 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=10 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=10 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=9 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Line Cancellation Test Change From Baseline at Day 90
|
-0.03 scores on a scale
Standard Deviation 0.03
|
-0.07 scores on a scale
Standard Deviation 0.11
|
-0.04 scores on a scale
Standard Deviation 0.10
|
-0.00 scores on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)
Outcome measures
| Measure |
NTx®-265 Low Dose
n=6 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=9 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=7 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=9 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Trails A Test Change From Baseline at Day 90
|
-11.33 seconds
Standard Deviation 22.20
|
-21.89 seconds
Standard Deviation 22.10
|
-13.29 seconds
Standard Deviation 21.91
|
-23.44 seconds
Standard Deviation 25.53
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)
Outcome measures
| Measure |
NTx®-265 Low Dose
n=6 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=6 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=7 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=9 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Trails B Test Change From Baseline at Day 90
|
-44.33 seconds
Standard Deviation 51.60
|
-41.33 seconds
Standard Deviation 62.89
|
-55.14 seconds
Standard Deviation 59.92
|
-22.78 seconds
Standard Deviation 71.22
|
SECONDARY outcome
Timeframe: Day 90Population: Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.
The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 - 5 is normal, whereas a score of 6 -15 suggests depression.
Outcome measures
| Measure |
NTx®-265 Low Dose
n=20 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=17 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=18 Participants
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=19 Participants
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Geriatric Depression Scale at Day 90
|
7.25 scores on a scale
Standard Deviation 4.24
|
3.88 scores on a scale
Standard Deviation 3.08
|
3.56 scores on a scale
Standard Deviation 2.77
|
4.74 scores on a scale
Standard Deviation 3.90
|
Adverse Events
NTx®-265 Low Dose
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
NTx®-265 Medium Dose
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
NTx®-265 High Dose
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NTx®-265 Low Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 participants at risk
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Nervous system disorders
Cerebral Vascular Accident
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Nervous system disorders
Hemorrhagic Transformation Stroke
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
4.2%
1/24 • Number of events 1 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
Other adverse events
| Measure |
NTx®-265 Low Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 Medium Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
|
NTx®-265 High Dose
n=24 participants at risk
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
|
Saline Placebo
n=24 participants at risk
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
12.5%
3/24 • Number of events 3 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
12.5%
3/24 • Number of events 3 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
General disorders
Pain
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
General disorders
Pyrexia
|
16.7%
4/24 • Number of events 4 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
25.0%
6/24 • Number of events 6 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
12.5%
3/24 • Number of events 3 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
|
Gastrointestinal disorders
Vomitting
|
12.5%
3/24 • Number of events 3 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
8.3%
2/24 • Number of events 2 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
0.00%
0/24 • Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60