Trial Outcomes & Findings for The Effect of Rivaroxaban in Sickle Cell Disease (NCT NCT02072668)
NCT ID: NCT02072668
Last Updated: 2020-04-13
Results Overview
Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).
COMPLETED
PHASE2
14 participants
Baseline, 4 weeks
2020-04-13
Participant Flow
15 subjects signed informed consent and were successfully screened. One subject withdrew during Baseline and prior to the first intervention and data from this individual are included in the baseline characteristics. One subject entered the second intervention period but was lost to follow up before receiving the intervention.
Participant milestones
| Measure |
Rivaroxaban, Then Placebo
Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.
Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks
|
Placebo, Then Rivaroxaban
Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.
Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks
|
|---|---|---|
|
First Intervention
STARTED
|
7
|
7
|
|
First Intervention
COMPLETED
|
7
|
7
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
7
|
7
|
|
Washout (2 Weeks)
COMPLETED
|
7
|
7
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
7
|
7
|
|
Second Intervention
COMPLETED
|
6
|
7
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Rivaroxaban, Then Placebo
Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.
Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks
|
Placebo, Then Rivaroxaban
Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.
Rivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks
|
|---|---|---|
|
Second Intervention
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Only measured on the participants who received study medication
Baseline characteristics by cohort
| Measure |
Study Participants
n=15 Participants
Participants who had a screening visit
|
|---|---|
|
Age, Customized
Age
|
39.00 years
STANDARD_DEVIATION 10.95 • n=15 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
Weight
|
68.22 kg
STANDARD_DEVIATION 11.69 • n=15 Participants
|
|
Height
|
169.40 cm
STANDARD_DEVIATION 10.56 • n=14 Participants • Only measured on the participants who received study medication
|
|
White Blood Cell (WBC) count
|
8.49 10^9 cells/L
STANDARD_DEVIATION 2.03 • n=15 Participants
|
|
Genotype - Hemoglobin SS (HbSS)
|
15 Participants
n=15 Participants
|
|
Platelet count
|
370.07 10^9 cells/L
STANDARD_DEVIATION 169.13 • n=15 Participants
|
|
Serum Creatinine
|
0.7 mg/dL
STANDARD_DEVIATION 0.22 • n=15 Participants
|
|
Prothrombin Time (PT)
|
12.54 sec
STANDARD_DEVIATION 0.99 • n=14 Participants • Only measured on the participants who received study medication
|
|
International Normalized Ratio (INR)
|
1.13 ratio
STANDARD_DEVIATION 0.09 • n=14 Participants • Only measured on the participants who received study medication
|
|
Partial Thromboplastin Time (PTT)
|
27.16 sec
STANDARD_DEVIATION 2.48 • n=14 Participants • Only measured on the participants who received study medication
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data reported only for those participants who completed both interventions.
Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Rivaroxaban
n=13 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)
|
40.9 pg/mL
Interval -115.5 to 197.2
|
10.7 pg/mL
Interval -84.5 to 105.8
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data reported only for those participants who completed both interventions.
Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Rivaroxaban
n=13 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)
|
-1.1 pg/mL
Interval -4.47 to 2.28
|
-0.54 pg/mL
Interval -1.69 to 0.62
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data analyzed for the 13 participants completing both interventions but results for 6 participants in each group fell outside the standard curve and could not be extrapolated.
Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility
Outcome measures
| Measure |
Rivaroxaban
n=7 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=7 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2
|
-1.14 pg/mL
Interval -4.13 to 1.85
|
0.36 pg/mL
Interval -3.48 to 4.2
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data analyzed for the 13 participants completing both interventions but results for 4 participants in the rivaroxaban group and 5 participants in the placebo group fell outside the standard curve and could not be extrapolated.
Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility
Outcome measures
| Measure |
Rivaroxaban
n=9 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=8 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8
|
0.95 pg/mL
Interval -41.83 to 43.72
|
-4.08 pg/mL
Interval -38.36 to 30.19
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.
high sensitivity C-reactive protein (hsCRP) was measured using Luminex MAP technology at the UNC core facility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.
myeloperoxidase (MPO) was measured using Luminex MAP technology at the UNC core facility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.
tumor necrosis factor alpha (TNF-a) was measured using Luminex MAP technology at the UNC core facility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.
secretory phospholipase A2 (sPLA2) was measured using Luminex MAP technology at the UNC core facility
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Biomarker evaluations were limited to VCAM-1 and IL-6 as those were thought more likely to reflect endothelial cell activation based on experience in recent studies.
levels of soluble intracellular adhesion molecule (sICAM) were measured using a commercially available ELISA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in TH1
|
0.84 seconds
Interval -0.79 to 2.47
|
-0.51 seconds
Interval -2.72 to 1.7
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in TM
|
-0.97 seconds
Interval -5.71 to 3.77
|
-2.01 seconds
Interval -6.82 to 2.81
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in AH
|
128 perfusion units*seconds
Interval -373.0 to 628.0
|
-1189 perfusion units*seconds
Interval -2597.0 to 218.0
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change in Ratio From Baseline to Week 4 in AH/AO
|
0.05 ratio of AH to AO
Interval -0.46 to 0.57
|
-0.81 ratio of AH to AO
Interval -2.05 to 0.42
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in PF
|
3.14 perfusion units
Interval -9.08 to 15.36
|
-12.62 perfusion units
Interval -26.63 to 1.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants randomized to each treatment were analyzed.
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF)
Outcome measures
| Measure |
Rivaroxaban
n=14 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in RF
|
0.29 perfusion units
Interval -1.47 to 2.05
|
-0.62 perfusion units
Interval -2.96 to 1.73
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data reported only for those participants who completed both interventions.
Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Rivaroxaban
n=13 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in TAT
|
-34.44 ug/mL
Interval -69.4 to 0.53
|
0.35 ug/mL
Interval -3.77 to 4.47
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Data reported only for those participants who completed both interventions.
Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Rivaroxaban
n=13 Participants
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 Participants
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Change From Baseline to Week 4 in D-Dimer
|
-471 ng/mL
Interval -1654.0 to 712.0
|
-1035 ng/mL
Interval -3880.0 to 1810.0
|
Adverse Events
Rivaroxaban
Placebo
Serious adverse events
| Measure |
Rivaroxaban
n=14 participants at risk
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 participants at risk
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Blood and lymphatic system disorders
painful crisis with bacteremia
|
0.00%
0/14 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
Other adverse events
| Measure |
Rivaroxaban
n=14 participants at risk
Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study
|
Placebo
n=13 participants at risk
Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study
|
|---|---|---|
|
Vascular disorders
pain crisis treated at home
|
28.6%
4/14 • Number of events 6 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
15.4%
2/13 • Number of events 2 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
General disorders
headache
|
14.3%
2/14 • Number of events 2 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
General disorders
chest pain
|
21.4%
3/14 • Number of events 3 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Blood and lymphatic system disorders
neutropenia
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
15.4%
2/13 • Number of events 3 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Skin and subcutaneous tissue disorders
ankle laceration
|
0.00%
0/14 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Skin and subcutaneous tissue disorders
tick bite
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Gastrointestinal disorders
diarrhea, nausea and vomiting
|
14.3%
2/14 • Number of events 3 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
General disorders
insomnia
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Skin and subcutaneous tissue disorders
tinea versicolor
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Gastrointestinal disorders
elevate liver enzymes
|
0.00%
0/14 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Respiratory, thoracic and mediastinal disorders
cough, fever, body aches, congestion
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
15.4%
2/13 • Number of events 2 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Musculoskeletal and connective tissue disorders
pain in lower extremities
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
7.7%
1/13 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
General disorders
dyspnea
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
Renal and urinary disorders
pelvic pressure with urination
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
|
General disorders
right flank pain
|
7.1%
1/14 • Number of events 1 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
0.00%
0/13 • Data collected from date of informed consent to end of study visit, approximately 3 months
The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
|
Additional Information
Dr. Kenneth Ataga
University of Tennessee Center for the Heath Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place