Trial Outcomes & Findings for Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B (NCT NCT03905655)
NCT ID: NCT03905655
Last Updated: 2023-11-07
Results Overview
Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Group 1
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
11
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 10.35 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 9.31 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
51 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Singapore
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
14 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Quantitative HBsAg
|
3.1 log10 IU/mL
STANDARD_DEVIATION 0.50 • n=5 Participants
|
3.0 log10 IU/mL
STANDARD_DEVIATION 0.45 • n=7 Participants
|
3.0 log10 IU/mL
STANDARD_DEVIATION 0.34 • n=5 Participants
|
2.8 log10 IU/mL
STANDARD_DEVIATION 0.51 • n=4 Participants
|
3.0 log10 IU/mL
STANDARD_DEVIATION 0.47 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: All subjects who received at least one dose of study medication
Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline
Outcome measures
| Measure |
Group 1
n=12 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=10 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=13 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Mean Change in Quantitative Hepatitis B Surface Antigen (qHBsAg)
|
0.0 log10 IU/mL
Standard Deviation 0.13
|
0.0 log10 IU/mL
Standard Deviation 0.90
|
0.0 log10 IU/mL
Standard Deviation 0.06
|
0.0 log10 IU/mL
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks after the end of treatmentPopulation: All participants who received at least one dose of study medication
Proportion of participants with sustained HBsAg loss with suppression of HBV DNA for 24 weeks after the end of treatment
Outcome measures
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Sustained HBsAg Loss With Suppression of HBV DNA for 24 Weeks After the End of Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All participants who received at least one dose of study medication
Change in mean Quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline to Day 3, Week 1, Week 2, Week 4, and Week 8
Outcome measures
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment
Day 3
|
0.0 log10 IU/mL
Standard Deviation 0.04
|
0.0 log10 IU/mL
Standard Deviation 0.08
|
0.0 log10 IU/mL
Standard Deviation 0.04
|
0.0 log10 IU/mL
Standard Deviation 0.06
|
|
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment
Week 1
|
0.0 log10 IU/mL
Standard Deviation 0.06
|
0.0 log10 IU/mL
Standard Deviation 0.05
|
0.0 log10 IU/mL
Standard Deviation 0.04
|
0.0 log10 IU/mL
Standard Deviation 0.05
|
|
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment
Week 2
|
0.0 log10 IU/mL
Standard Deviation 0.05
|
0.0 log10 IU/mL
Standard Deviation 0.11
|
0.0 log10 IU/mL
Standard Deviation 0.04
|
0.1 log10 IU/mL
Standard Deviation 0.05
|
|
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment
Week 4
|
0.0 log10 IU/mL
Standard Deviation 0.08
|
0.0 log10 IU/mL
Standard Deviation 0.09
|
0.0 log10 IU/mL
Standard Deviation 0.05
|
0.1 log10 IU/mL
Standard Deviation 0.07
|
|
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on Treatment
Week 8
|
0.0 log10 IU/mL
Standard Deviation 0.06
|
0.0 log10 IU/mL
Standard Deviation 0.14
|
-0.1 log10 IU/mL
Standard Deviation 0.07
|
0.0 log10 IU/mL
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who received at least one dose of study medication
Proportion of participants with HBsAg loss defined as quantitative HBsAg below the lower limit of quantitation at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Outcome measures
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Week 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who received at least one dose of study medication
Proportion of participants with hepatitis B surface antigen (HBsAg) seroconversion defined as HBsAg loss and gain of anti-hepatitis B antibodies at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Outcome measures
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who received at least one dose of study medication
Proportion of participants with hepatitis B virus DNA suppression defined as hepatitis B virus DNA below the lower limit of quantitation (20 IU/mL) at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Outcome measures
| Measure |
Group 1
n=13 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Hepatitis B Virus DNA Suppression
Week 4
|
13 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
|
Hepatitis B Virus DNA Suppression
Day 3
|
13 Participants
|
13 Participants
|
11 Participants
|
13 Participants
|
|
Hepatitis B Virus DNA Suppression
Week 1
|
13 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
|
Hepatitis B Virus DNA Suppression
Week 2
|
13 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
|
Hepatitis B Virus DNA Suppression
Week 8
|
13 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
|
Hepatitis B Virus DNA Suppression
Week 12
|
13 Participants
|
13 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who received at least one dose of study medication
Mean change in Fibrosis-4 (FIB-4) score from Baseline to Week 1, Week 2, Week 4, Week 8, and Week 12. FIB-4 score is calculated as (age in years \* Aspartate aminotransferase (AST) in U/L)/(platelet count in 10\^9 U/L \* square root of alanine aminotransferase (ALT) in U/L). FIB-4 scores under 1.45 have a negative predictive value of 90% for advanced fibrosis (better outcome) and FIB-4 scores \>3.25 have a positive predictive value of 65% for advanced fibrosis (worse outcome). See Sterling RK, Lissen E, Clumeck N, et. al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV co-infection. Hepatology 2006;43:1317-1325.
Outcome measures
| Measure |
Group 1
n=12 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=10 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=13 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Change in Fibrosis-4 (FIB-4) Score
Week 1
|
-1.7 FIB-4 Score
Standard Deviation 0.88
|
-2.8 FIB-4 Score
Standard Deviation 0.97
|
-2.9 FIB-4 Score
Standard Deviation 2.68
|
-2.0 FIB-4 Score
Standard Deviation 0.86
|
|
Change in Fibrosis-4 (FIB-4) Score
Week 2
|
-1.4 FIB-4 Score
Standard Deviation 1.08
|
-2.8 FIB-4 Score
Standard Deviation 1.06
|
-2.9 FIB-4 Score
Standard Deviation 2.61
|
-1.8 FIB-4 Score
Standard Deviation 0.88
|
|
Change in Fibrosis-4 (FIB-4) Score
Week 4
|
-1.7 FIB-4 Score
Standard Deviation 0.88
|
-2.9 FIB-4 Score
Standard Deviation 1.03
|
-2.9 FIB-4 Score
Standard Deviation 2.81
|
-1.8 FIB-4 Score
Standard Deviation 1.07
|
|
Change in Fibrosis-4 (FIB-4) Score
Week 8
|
-1.7 FIB-4 Score
Standard Deviation 1.00
|
-2.9 FIB-4 Score
Standard Deviation 1.05
|
-2.8 FIB-4 Score
Standard Deviation 2.67
|
-2.1 FIB-4 Score
Standard Deviation 0.91
|
|
Change in Fibrosis-4 (FIB-4) Score
Week 12
|
0.0 FIB-4 Score
Standard Deviation 0.57
|
-1.2 FIB-4 Score
Standard Deviation 1.06
|
-1.0 FIB-4 Score
Standard Deviation 1.51
|
-0.8 FIB-4 Score
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline to end of treatmentPopulation: All participants who received at least one dose of study medication
Mean change in FibroScan score from Baseline to end of treatment. Fibroscan is a kind of liver elastography measuring liver stiffness in kilopascals (kPa). Higher results are consistent with liver disease (worse outcome).
Outcome measures
| Measure |
Group 1
n=5 Participants
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=3 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=4 Participants
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=3 Participants
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Change in FibroScan Score
|
0.0 kilopascals (kPa)
Standard Deviation 1.41
|
2.0 kilopascals (kPa)
Standard Deviation 1.73
|
0.0 kilopascals (kPa)
Standard Deviation 0.82
|
1.3 kilopascals (kPa)
Standard Deviation 1.53
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 4
Serious events: 1 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1
n=13 participants at risk
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 participants at risk
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 participants at risk
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 participants at risk
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Hepatobiliary disorders
Mixed hepatocellular cholangiocarcinoma
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
Other adverse events
| Measure |
Group 1
n=13 participants at risk
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
|
Group 2
n=13 participants at risk
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 3
n=11 participants at risk
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Placebo Oral Tablet: Number of placebo tablets administered orally depends on the arm
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
Group 4
n=14 participants at risk
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Nitazoxanide: Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Eye disorders
Scleral discolouration
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
15.4%
2/13 • Number of events 4 • Up to 60 weeks
|
15.4%
2/13 • Number of events 2 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
21.4%
3/14 • Number of events 3 • Up to 60 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
15.4%
2/13 • Number of events 2 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
18.2%
2/11 • Number of events 2 • Up to 60 weeks
|
14.3%
2/14 • Number of events 3 • Up to 60 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Number of events 5 • Up to 60 weeks
|
15.4%
2/13 • Number of events 2 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
42.9%
6/14 • Number of events 8 • Up to 60 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 2 • Up to 60 weeks
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Faeces soft
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
18.2%
2/11 • Number of events 2 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 2 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 2 • Up to 60 weeks
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Fatigue
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
General disorders
Hunger
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Thirst
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Infections and infestations
Influenza
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
14.3%
2/14 • Number of events 2 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
28.6%
4/14 • Number of events 4 • Up to 60 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
28.6%
4/14 • Number of events 4 • Up to 60 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
14.3%
2/14 • Number of events 2 • Up to 60 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Investigations
Heart rate increased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
18.2%
2/11 • Number of events 2 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 3 • Up to 60 weeks
|
7.7%
1/13 • Number of events 2 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Renal and urinary disorders
Chromaturia
|
15.4%
2/13 • Number of events 2 • Up to 60 weeks
|
61.5%
8/13 • Number of events 8 • Up to 60 weeks
|
72.7%
8/11 • Number of events 10 • Up to 60 weeks
|
78.6%
11/14 • Number of events 11 • Up to 60 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 2 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 2 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
General disorders
Chest pain
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Investigations
Blood urine present
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Investigations
Electrocardiogram abnormal
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
7.1%
1/14 • Number of events 1 • Up to 60 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/13 • Up to 60 weeks
|
7.7%
1/13 • Number of events 1 • Up to 60 weeks
|
0.00%
0/11 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • Up to 60 weeks
|
0.00%
0/13 • Up to 60 weeks
|
9.1%
1/11 • Number of events 1 • Up to 60 weeks
|
0.00%
0/14 • Up to 60 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place