| Primary | Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE) | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of treatment-emergent adverse events (TEAEs). | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| | | Title | Denominators | Categories |
|---|
| No of participants with at least one TEAE | | | | TEAE maximum severity: Grade 1 (mild) | | | | TEAE maximum severity: Grade 2 (moderate) | | |
| |
| Primary | Number of NTZ Treated Participants Presenting Any Study Drug Related TEAE | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related treatment-emergent adverse events (TEAEs). | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting Any SAE | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of serious adverse events (SAEs). | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| | |
| Primary | Number of NTZ Treated Participants Presenting Study Drug-Related SAE | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related serious adverse events (SAEs). | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Deaths Due to AE | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of deaths due to adverse events (AEs). | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| | |
| Primary | Number of NTZ Treated Participants Presenting Any AE Leading to Withdrawal From Study or Study Drug | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of adverse events (AEs) leading to withdrawal from study or study drug. | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting Any Study Drug-related AE Leading to Withdrawal From Study or Study Drug | To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related adverse events (AEs) leading to withdrawal from study or study drug | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Clinical Laboratory Evaluations | To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing clinical laboratory evaluations. Changes in clinical laboratory evaluations were considered clinically significant or not as per Investigator judgment. | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Vital Signs | To assess the safety and tolerability of NTZ after 24 weeks of treatment by measuring vital signs. Changes in vital signs were considered clinically significant or not as per Investigator judgement | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Electrocardiogram Parameters | To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing electrocardiograms (ECGs). Changes in ECGs parameters were considered clinically significant or not as per Investigator judgement. | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Primary | Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Physical Examinations | To assess the safety and tolerability of NTZ after 24 weeks of treatment by conducting physical examinations. Changes in physical examinations were considered clinically significant or not as per Investigator judgement. | The Safety Analysis Set consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment | Change in Lumican Fractional Synthesis Rate (FSR) from baseline to end of treatment evaluated through the use of deuterated water. Lumican is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR). This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | pools per day | | From baseline to end of treatment (Visit 10, Week 24 or early termination) | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment | Percent Change in Lumican FSR from baseline to end of treatment evaluated through the use of deuterated water. Lumican is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR). This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | percentage of change | | From baseline to end of treatment (Visit 10, Week 24 or early termination) | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment | Change in transforming growth factor beta-induced-protein (TGFBI) Fractional Synthesis Rate (FSR) from baseline to end of treatment evaluated through the use of deuterated water. TGFBI is a marker indicative of hepatic fibrogenesis with its turnover assessed by FSR. This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results were expressed as FSR of these proteins. | | Posted | | Mean | Standard Deviation | pools per day | | From baseline to end of treatment (Visit 10, Week 24 or early termination) | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment | Percent Change in transforming growth factor beta-induced protein (TGFBI) FSR from baseline to end of treatment evaluated through the use of deuterated water. TGFBI is a marker indicative of hepatic fibrogenesis with its turnover assessed by Fractional Synthesis Rate (FSR). This innovative method of metabolic labelling is based on the concept that liver status could be determined by measuring the ratio of newly synthesized/pre-existing proteins. The turnover rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients were given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry was used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results were expressed as FSR of these proteins. | | Posted | | Mean | Standard Deviation | percentage of change | | From baseline to end of treatment (Visit 10, Week 24 or early termination) | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan® | FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit. The CAP score is a measurement of fatty change in the liver, naming the steatosis grade. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m. 100 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis (steatosis S1), 260 to 290 dB/m indicates moderate steatosis (steatosis S2), and a CAP score greater than 290 dB/m indicates severe steatosis (steatosis S3). | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | dB/m | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan® | FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit. The CAP score is a measurement of fatty change in the liver, naming the steatosis grade.The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m. 100 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis (steatosis S1), 260 to 290 dB/m indicates moderate steatosis (steatosis S2), and a CAP score greater than 290 dB/m indicates severe steatosis (steatosis S3). | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan® | FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit. The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa indicating the abscence of abscence of fibrosis (F0) or a potential fibrosis of stage 1 (F1). The highest possible result is 75 kPa indicating advanced liver fibrosis of stage 4 (F4). | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | kPa | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated by FibroScan® | FibroScan is a specialized ultrasound machine that measures fibrosis (scarring) and steatosis (fatty change) in the liver. It was required that each subject's FibroScan® assessments be done with the same type of probe at each study visit. The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa indicating the abscence of abscence of fibrosis (F0) or a potential fibrosis of stage 1 (F1). The highest possible result is 75 kPa indicating advanced liver fibrosis of stage 4 (F4). | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | Posted | | Mean | Standard Deviation | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE) | Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 13 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | kPa | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Liver Stiffness From Baseline to Week 12 as Evaluated Through the Use Magnetic Resonance Elastography (MRE) | Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 13 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE) | Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 12 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | kPa | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Liver Stiffness From Baseline to End of Treatment as Evaluated Through the Use Magnetic Resonance Elastography (MRE) | Liver stiffness was assessed by MRE. It was recommended that each subject's radiological assessment was performed using the same procedure for each study visit. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 12 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Alpha-2 Macroglobulin From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | mg/dL | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Alpha-2 Macroglobulin From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Alpha-2 Macroglobulin From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | mg/dL | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Alpha-2 Macroglobulin From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibroblast Growth Factor 19 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | ng/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibroblast Growth Factor 19 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | ng/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibroblast Growth Factor 19 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibroblast Growth Factor 21 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | ng/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibroblast Growth Factor 21 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | ng/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibroblast Growth Factor 21 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Human Chitinase 3-like 1 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | ng/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Human Chitinase 3-like 1 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Human Chitinase 3-like 1 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | ng/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Human Chitinase 3-like 1 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Hyaluronic Acid From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | µg/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Hyaluronic Acid From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Hyaluronic Acid From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | µg/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Hyaluronic Acid From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | score | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | score | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Liver Fibrosis Score Enhanced Liver Fibrosis (ELF) From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. ELF score is a continuous (not a categorical) variable with < 9.8 indicative of low risk of progression to cirrhosis and >=9.8 to >11.3 indicative of mid-risk and >=11.30 indicative of higher risk. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in M30 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | U/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in M30 Biomarker From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in M30 Biomarker From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | U/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in M30 Biomarker From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in M65 Biomarker From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | U/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in M65 Biomarker From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in M65 Biomarker From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | U/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in M65 Biomarker From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in miR34a Fold From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | fold change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in miR34a Fold From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in miR34a Fold From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | fold change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in miR34a Fold From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 16 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Pro-C3 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | µg/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Pro-C3 From Baseline to Week 12 | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Pro-C3 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | µg/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Pro-C3 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Pro-C6 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | µg/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Pro-C6 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Pro-C6 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | µg/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Pro-C6 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Procollagen 3 N-terminal Pro-peptide From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | µg/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Procollagen 3 N-terminal Pro-peptide From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Procollagen 3 N-terminal Pro-peptide From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | µg/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Procollagen 3 N-terminal Pro-peptide From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | µg/L | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to Week 12 | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). 21 patients were analyzed for this Outcome Measure, as all patients had a result both at baseline and at the week 12 visit. | Posted | | Median | Full Range | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | µg/L | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Tissue Inhibitor of Metalloproteinase 1 From Baseline to End of Treatment | Non-invasive Fibrosis Biomarkers were assessed in blood samples. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 17 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Median | Full Range | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to Week 12 | NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | score | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to Week 12 | NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to End of Treatment | NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 8 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | score | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score From Baseline to End of Treatment | NAFLD NFS : < -1.5 for low probability of fibrosis, > -1.5 to < 0.67 for intermediate probability of fibrosis, and > 0.67 for high probability of fibrosis. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 8 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibrosis-4 Score From Baseline to Week 12 | Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | score | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibrosis-4 Score From Baseline to Week 12 | Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 20 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the week 12 visit. | Posted | | Mean | Standard Deviation | percentage of change | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Change in Fibrosis-4 Score From Baseline to End of Treatment | Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 8 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | score | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |
| Secondary | Percent Change in Fibrosis-4 Score From Baseline to End of Treatment | Fibrosis-4 score : FIB4 < 1.3 is not consistent with F3-F6 disease. FIB4 of 1.3 to <2.67 is indeterminate for F3-F6 disease. > 2.67 is consistent F3 to F6. | The Full Analysis Set consisted of all patients who met the eligibility criteria and enrolled into the study (Visit 1 Day 1). There were 8 patients analyzed for this Outcome Measure, corresponding to the patients having a result both at baseline and at the end of treatment visit. | Posted | | Mean | Standard Deviation | percentage of change | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | NTZ 500 mg BID | Open label group: all patients were to receive study drug Nitazoxanide 500mg BID for 24 weeks. |
| |