Trial Outcomes & Findings for Acute Effects of Inhaled Treprostinil in Fontan Patients (NCT NCT02769624)
NCT ID: NCT02769624
Last Updated: 2020-07-29
Results Overview
At rest and then following maximal exercise, shear wave ultrasound elastography will be performed to assess if the study medication shows an improvement in liver stiffness (reduction in m/s number) following maximal exercise versus at rest.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At rest and following dose 2
Results posted on
2020-07-29
Participant Flow
This was a randomized, placebo-controlled, double-blind, crossover trial conducted at one center. Healthy Fontan patients were recruited from within the medical center's Fontan management program for participation in this trial. Each patient completed three study visits over the course of six weeks.
Each participant came in for a baseline visit initially and then for the second visit, they were randomly assigned to receiving either the study medication or placebo. At the third visit, the patient received the opposite of what they received at visit two.
Participant milestones
| Measure |
Treprostinil, Then Placebo
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo, Then Treprostinil
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treprostinil, Then Placebo
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo, Then Treprostinil
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treprostinil Crossover With Placebo
n=14 Participants
Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.
If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
|
Cardiac Anatomy
Tricuspid Atresia
|
4 Participants
n=14 Participants
|
|
Cardiac Anatomy
Double Inlet Left Ventricle
|
2 Participants
n=14 Participants
|
|
Cardiac Anatomy
Pulmonary Atresia
|
2 Participants
n=14 Participants
|
|
Cardiac Anatomy
Hypoplastic Left Heart Syndrome
|
6 Participants
n=14 Participants
|
|
Fontan Type
Atrio-pulmonary Fontan
|
2 Participants
n=14 Participants
|
|
Fontan Type
Lateral Tunnel
|
9 Participants
n=14 Participants
|
|
Fontan Type
Extracardiac Conduit
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: At rest and following dose 2At rest and then following maximal exercise, shear wave ultrasound elastography will be performed to assess if the study medication shows an improvement in liver stiffness (reduction in m/s number) following maximal exercise versus at rest.
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Reduction in Liver Stiffness Through the Measurement of Shear Wave Ultrasound Elastography (m/s)
Rest
|
2.39 m/s
Standard Deviation 0.67
|
2.38 m/s
Standard Deviation 0.71
|
|
Reduction in Liver Stiffness Through the Measurement of Shear Wave Ultrasound Elastography (m/s)
Following maximal exercise
|
2.79 m/s
Standard Deviation 0.54
|
2.89 m/s
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: At rest and at peak incremental exerciseVenous pressure was measured both at rest and during an incremental ramp exercise test. Comparison was made to evaluate if the treprostinil study medication had a different effect in venous pressure measurements during peak exercise versus placebo.
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Venous Pressure (mmHg) at Rest and Peak Exercise
Rest
|
12.8 mmHg
Standard Deviation 3.08
|
12.1 mmHg
Standard Deviation 2.43
|
|
Venous Pressure (mmHg) at Rest and Peak Exercise
Peak Incremental Exercise
|
22.8 mmHg
Standard Deviation 6.16
|
22.6 mmHg
Standard Deviation 8.04
|
SECONDARY outcome
Timeframe: Immediately following dose 3A constant work rate exercise test will be performed to determine exercise endurance
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Exercise Endurance Time (in Minutes)
|
5.19 Minutes
Standard Deviation 0.89
|
5.82 Minutes
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Maximal exercise test (5-10 minutes)Measuring the difference in peak/maximal VO2 during incremental exercise testing to assess if the response during peak exercise is different when utilizing treprostinil versus a placebo.
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Peak Volume of Oxygen Consumption (VO2) (ml/kg/Min)
|
23.4 ml/kg/min
Standard Deviation 6.67
|
24.6 ml/kg/min
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: Maximal exercise test (5-10 minutes)Measuring the difference in peak/maximal VE/VCO2 during incremental exercise testing to assess if the response during peak exercise is different when utilizing treprostinil versus a placebo. The VE/VCO2 slope is used to show the relationship between minute ventilation and carbon dioxide production.
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Minute Volume and Carbon Dioxide Volume Slope (VE/VCO2) During Incremental Exercise
|
26.8 unitless
Standard Deviation 4.95
|
26.1 unitless
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Maximal exercise test (5-10 minutes)Measuring the difference in VO2 at anaerobic threshold of an incremental exercise test to assess the variance in response with treprostinil versus placebo
Outcome measures
| Measure |
Treprostinil
n=14 Participants
A dose of 18mcg (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) inhalation solution is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit.
Treprostinil: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=14 Participants
A dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplies in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit.
Placebo: 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
VO2 (ml/kg/Min) at Anaerobic Threshold
|
17.3 ml/kg/min
Standard Deviation 3.63
|
18.1 ml/kg/min
Standard Deviation 5.36
|
Adverse Events
Treprostinil
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treprostinil
n=14 participants at risk
Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.
If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
Placebo
n=15 participants at risk
Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.
If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
71.4%
10/14 • Number of events 10 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
0.00%
0/15 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
14.3%
2/14 • Number of events 2 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
0.00%
0/15 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 4 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
0.00%
0/15 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Ear and labyrinth disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Hepatobiliary disorders
Increase in Liver Lab Values
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
0.00%
0/15 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Cardiac disorders
Abnormal ECG Rhythm
|
0.00%
0/14 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
21.4%
3/14 • Number of events 3 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
0.00%
0/15 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
General disorders
Weakness
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
|
Cardiac disorders
Lowered blood pressure
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed and recorded following signing of informed consent through two weeks following the last study visit (period ranging from 6-9 weeks).
Events that are unexpected and considered to be related or possibly related to the study procedures as well as breaches of confidentiality, and protocol violations were reported to the IRB as soon as possible after discovery of the event. All adverse events will be classified by the PI for relationship, severity, and expectedness. Events not meeting the criteria for prompt reporting were reported to the Institutional Review Board (IRB) at the time of continuing review.
|
Additional Information
Katy Fischesser
Cincinnati Children's Hospital Medical Center
Phone: 513-803-5191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place