Trial Outcomes & Findings for A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis (NCT NCT03423121)
NCT ID: NCT03423121
Last Updated: 2023-05-03
Results Overview
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-05-03
Participant Flow
Out of the 59 people that got enrolled, four (4) were lost to follow-up and did not come for a baseline visit, while one (1) was not eligible based on the screening visit assessments, ending up with 54 people.
Participant milestones
| Measure |
TUDCA Treatment
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
TUDCA Treatment
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
TUDCA Treatment
n=28 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=26 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10 • n=7 Participants
|
57 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants who received at least one dose of the intervention and came back for a follow-up visit.
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
Outcome measures
| Measure |
TUDCA Treatment
n=26 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=21 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-related Adverse Event
|
10 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants who received at least one dose of the intervention and came back for a follow-up visit.
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms.
Outcome measures
| Measure |
TUDCA Treatment
n=26 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=21 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Number of Total Treatment-related Adverse Events
|
11 total treatment-related adverse events
|
8 total treatment-related adverse events
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants who received at least one dose of the intervention and came back for a follow-up visit.
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms. AE incidence will be measured as total number of events per 1000 exposure years.
Outcome measures
| Measure |
TUDCA Treatment
n=26 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=21 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Incidence of Treatment-related Adverse Events (AE)
|
1218 total events per 1000 exposure years
|
1061 total events per 1000 exposure years
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksPopulation: All participants who received at least one dose of the intervention and had at least two measurements of bile acid levels in plasma.
The change of targeted bile acid levels over the course of 16 weeks (duration of the study) is reported. Bile acid levels (ng/mL) were log transformed before analysis to approximate normal distribution. Units are log(levels) per 16 weeks. Values are derived from linear mixed-effects models.
Outcome measures
| Measure |
TUDCA Treatment
n=23 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=20 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Change in Fasting Bile Acid Levels in Plasma
Chenodeoxycholic Acid
|
0.44 log(levels[ng/mL]) per 16 weeks
Interval -0.14 to 1.02
|
0.48 log(levels[ng/mL]) per 16 weeks
Interval -0.13 to 1.09
|
|
Change in Fasting Bile Acid Levels in Plasma
Cholic Acid
|
-0.4 log(levels[ng/mL]) per 16 weeks
Interval -1.04 to 0.23
|
0.58 log(levels[ng/mL]) per 16 weeks
Interval -0.21 to 1.38
|
|
Change in Fasting Bile Acid Levels in Plasma
Deoxycholic Acid
|
0.14 log(levels[ng/mL]) per 16 weeks
Interval -0.21 to 0.48
|
0.46 log(levels[ng/mL]) per 16 weeks
Interval 0.13 to 0.8
|
|
Change in Fasting Bile Acid Levels in Plasma
Glycochenodeoxycholic Acid
|
0.3 log(levels[ng/mL]) per 16 weeks
Interval -0.14 to 0.74
|
-0.09 log(levels[ng/mL]) per 16 weeks
Interval -0.63 to 0.44
|
|
Change in Fasting Bile Acid Levels in Plasma
Glycocholic Acid
|
-0.02 log(levels[ng/mL]) per 16 weeks
Interval -0.46 to 0.42
|
-0.32 log(levels[ng/mL]) per 16 weeks
Interval -0.88 to 0.24
|
|
Change in Fasting Bile Acid Levels in Plasma
Glycodeoxycholic Acid
|
0.1 log(levels[ng/mL]) per 16 weeks
Interval -0.36 to 0.56
|
0.14 log(levels[ng/mL]) per 16 weeks
Interval -0.36 to 0.63
|
|
Change in Fasting Bile Acid Levels in Plasma
Glycolithocholic Acid
|
0.9 log(levels[ng/mL]) per 16 weeks
Interval 0.33 to 1.47
|
0.35 log(levels[ng/mL]) per 16 weeks
Interval -0.01 to 0.71
|
|
Change in Fasting Bile Acid Levels in Plasma
Glycoursodeoxycholic Acid
|
2.3 log(levels[ng/mL]) per 16 weeks
Interval 1.32 to 3.29
|
0.14 log(levels[ng/mL]) per 16 weeks
Interval -0.35 to 0.64
|
|
Change in Fasting Bile Acid Levels in Plasma
Lithocholic Acid
|
0.75 log(levels[ng/mL]) per 16 weeks
Interval 0.28 to 1.22
|
0.2 log(levels[ng/mL]) per 16 weeks
Interval -0.12 to 0.51
|
|
Change in Fasting Bile Acid Levels in Plasma
Taurochenodeoxycholic Acid
|
0.05 log(levels[ng/mL]) per 16 weeks
Interval -0.49 to 0.59
|
-0.04 log(levels[ng/mL]) per 16 weeks
Interval -0.64 to 0.57
|
|
Change in Fasting Bile Acid Levels in Plasma
Taurocholic Acid
|
-0.23 log(levels[ng/mL]) per 16 weeks
Interval -0.74 to 0.28
|
-0.26 log(levels[ng/mL]) per 16 weeks
Interval -0.83 to 0.3
|
|
Change in Fasting Bile Acid Levels in Plasma
Taurodeoxycholic Acid
|
-0.31 log(levels[ng/mL]) per 16 weeks
Interval -0.87 to 0.25
|
0.1 log(levels[ng/mL]) per 16 weeks
Interval -0.45 to 0.65
|
|
Change in Fasting Bile Acid Levels in Plasma
Taurolithocholic Acid
|
0.15 log(levels[ng/mL]) per 16 weeks
Interval -0.19 to 0.5
|
0.14 log(levels[ng/mL]) per 16 weeks
Interval -0.13 to 0.42
|
|
Change in Fasting Bile Acid Levels in Plasma
Tauroursodeoxycholic Acid
|
2.52 log(levels[ng/mL]) per 16 weeks
Interval 1.3 to 3.73
|
-0.22 log(levels[ng/mL]) per 16 weeks
Interval -0.52 to 0.07
|
|
Change in Fasting Bile Acid Levels in Plasma
Ursodeoxycholic Acid
|
1.89 log(levels[ng/mL]) per 16 weeks
Interval 0.76 to 3.02
|
0.37 log(levels[ng/mL]) per 16 weeks
Interval -0.03 to 0.78
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksPopulation: All participants who received at least one dose of the intervention and returned at least two stool kits were included in the analysis
Change in Shannon index of the gut microbiota between baseline and end of study (16 weeks). Shot-gun metagenomic sequencing in first morning stool specimen was utilized to derive the microbiome composition. Higher values of the index indicate more diversity in the microbial community. The minimum value the Shannon index can take is 0 (no diversity). There is no upper limit to the index.
Outcome measures
| Measure |
TUDCA Treatment
n=21 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=13 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study
|
-0.15 score on a scale
Interval -0.47 to 0.18
|
0.06 score on a scale
Interval -0.3 to 0.41
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksPopulation: All participants who received at least one dose of the intervention and had at least two blood draws that resulted in PBMC isolation were included in the analysis
Change in flow cytometric assessments over the course of 16 weeks (duration of the study). Cells are expressed as ratios of their parent types. Units reported as change in the ratio per 16 weeks. Values are derived from linear mixed-effects models.
Outcome measures
| Measure |
TUDCA Treatment
n=23 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=19 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
T helper memory cells
|
-1.34 parent cell ratio per 16 weeks
Interval -4.63 to 1.96
|
3.05 parent cell ratio per 16 weeks
Interval -1.88 to 7.98
|
|
Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
Cytotoxic T memory cells
|
-1.9 parent cell ratio per 16 weeks
Interval -5.42 to 1.61
|
2.61 parent cell ratio per 16 weeks
Interval -2.62 to 7.84
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksPopulation: All participants who received at least one dose of the intervention and completed at least two MSQOL questionnaires were included in the analysis
Change in physical and mental health scores as assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument over the course of 16 weeks (duration of the study). This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. Two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. Higher scores suggest a better quality of life. Scores can range from 0 to 100.
Outcome measures
| Measure |
TUDCA Treatment
n=19 Participants
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=19 Participants
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
MSQOL - Physical Component
|
-0.15 score on a scale
Interval -4.37 to 4.07
|
0.01 score on a scale
Interval -4.7 to 4.71
|
|
Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
MSQOL - Mental Component
|
-0.44 score on a scale
Interval -4.48 to 3.61
|
4.57 score on a scale
Interval -0.09 to 9.23
|
Adverse Events
TUDCA Treatment
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TUDCA Treatment
n=26 participants at risk
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=21 participants at risk
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
3.8%
1/26 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
0.00%
0/21 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
Other adverse events
| Measure |
TUDCA Treatment
n=26 participants at risk
Tauroursodeoxycholic acid (Taurolite) 250 mg four capsules by mouth, twice daily for 16 weeks.
Tauroursodeoxycholic Acid: Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
|
Placebo Oral Capsule
n=21 participants at risk
Placebo oral capsule four capsules by mouth, twice daily for 16 weeks.
Placebo oral capsule: Participants will be given four capsules of the placebo twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal cramps
|
7.7%
2/26 • Number of events 2 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
0.00%
0/21 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
7.7%
2/26 • Number of events 2 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
0.00%
0/21 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
7.7%
2/26 • Number of events 2 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Gastrointestinal disorders
Increased flatulence
|
3.8%
1/26 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/26 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/26 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
4.8%
1/21 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Skin and subcutaneous tissue disorders
Facial rash (left)
|
3.8%
1/26 • Number of events 1 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
0.00%
0/21 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/26 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
9.5%
2/21 • Number of events 2 • 16 weeks
All participants who received at least one dose of the intervention and had at least one follow-up visit in order to be evaluated for adverse events were considered at risk. Two (2) participants in the TUDCA group and five (5) participants in the placebo group were lost to follow-up or withdrew and therefore the number at risk is 26 and 21 for the TUDCA and placebo group, respectively.
|
Additional Information
Dr. Pavan Bhargava
Johns Hopkins University School of Medicine
Phone: 410-614-1522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place