| Primary | Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | Cure is defined as sero-reduction (in subjects ≥8 months to <18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density [OD]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control. | | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | At 12 months post-treatment | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00032.9(26.4 to 39.3)
- OG00118.9(11.2 to 26.7)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Difference in cure rate | 14 | | | 2-Sided | 95 | 3.7 | 24.2 | | | | | Other | | |
|
| Primary | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen. | Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay [IHA]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported. | | Posted | | Number | | Participants | | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) Treatment administered in Part 1; no study drug was administered in Part 2 |
| |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Measured in sub-population. | | Posted | | Median | Full Range | ug/L | | At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | Measured in sub-population. | | Posted | | Median | Full Range | ug/L | | At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | The evaluation was based on clinical examinations. Measured in sub-population. | | Posted | | Median | Full Range | ug/L | | At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | Measured in sub-population. | | Posted | | Median | Full Range | ug/L | | At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen | Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay [IHA]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported. | | Posted | | Number | | Participants | | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) Treatment administered in Part 1; no study drug was administered in Part 2 |
| |
| Secondary | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total | | Posted | | Number | | Participants | | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days: Chagas-related Cardiomyopathy | | | OG001 | Nifurtimox 30 Days: Chagas-related Cardiomyopathy | |
| |
| Secondary | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total | | Posted | | Number | | Participants | | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days: Chagas-related Cardiomyopathy | | | OG001 | Nifurtimox 30 Days: Chagas-related Cardiomyopathy | |
| |
| Secondary | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Summary and change from baseline of optical density values measured by total purified antigen ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted. | | Posted | | Mean | Standard Deviation | Optical density | | Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) Treatment administered in Part 1; no study drug was administered in Part 2 | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) Treatment administered in Part 1; no study drug was administered in Part 2 |
| |
| Secondary | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Summary and change from baseline of optical density values measured by recombinant ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted. | | Posted | | Mean | Standard Deviation | Optical density | | Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) Treatment administered in Part 1; no study drug was administered in Part 2 | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) Treatment administered in Part 1; no study drug was administered in Part 2 |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | At Visit 1 (before treatment started) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 7 days (Visit 3) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 30 days (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 60 days (Visit 8; end of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 90 days (Visit 9 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 240 days (Visit 10 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | The evaluation was based on clinical examinations. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | | | Posted | | Count of Participants | | Participants | | Up to 90 days (Visit 9 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug | | Posted | | Count of Participants | | Participants | | up to 7 days after last application of study drug | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2. In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported. | | Posted | | Count of Participants | | Participants | | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) Treatment administered in Part 1; no study drug was administered in Part 2 | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) Treatment administered in Part 1; no study drug was administered in Part 2 |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs) | Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators | Clinical significance of abnormal ECG was based on the judgement of the investigator | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline and up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline and up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | | | Posted | | Mean | Standard Deviation | BREATHS/MIN | | Baseline and up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| |
| Secondary | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | | | Posted | | Mean | Standard Deviation | BEATS/MIN | | Baseline and up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
|---|
| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
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| Secondary | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | | | Posted | | Mean | Standard Deviation | °C | | Baseline and up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | | OG001 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
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| Other Pre-specified | Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole) | This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control. | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Nifurtimox 60 Days / Arm 1 | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) |
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| Other Pre-specified | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Detectable = Detec qPCR Non-reactive = Nonreac ELISA Non-detectable = Nondetec qPCR Non evaluable = Noneval qPCR qPCR Missing = Miss qPCR Missing conventional testing = Miss ELISA | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Nifurtimox 60 Days Reactive Detectable | Nifurtimox 60 days with Reac ELISA and Detec qPCR | | OG001 | Nifurtimox 60 Days Reactive Non-detectable | Nifurtimox 60 days with Reac ELISA and Nondetec qPCR | | OG002 | Nifurtimox 60 Days Non-reactive Detectable | Nifurtimox 60 days with Nonreac ELISA and Detec qPCR | | OG003 | Nifurtimox 60 Days Non-reactive Non-detectable | Nifurtimox 60 days with Nonreac ELISA and Nondetec qPCR | |
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| Other Pre-specified | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive = Nonreac F29 | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Nifurtimox 60 Days Reactive and Reactive | Nifurtimox 60 days with Reac ELISA and Reac F29 | | OG001 | Nifurtimox 60 Days Reactive and Non-reactive | Nifurtimox 60 days with Reac ELISA and Nonreac F29 | | OG002 | Nifurtimox 60 Days Non-reactive and Reactive | Nifurtimox 60 days with Nonreac ELISA and Reac F29 | | OG003 | Nifurtimox 60 Days Non-reactive and Non-reactive | Nifurtimox 60 days with Nonreac ELISA and Nonreac F29 | | OG004 | Nifurtimox 30 Days Reactive and Reactive |
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| Other Pre-specified | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive= Nonreac F29 | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Nifurtimox 60 Days Reactive and Reactive | Nifurtimox 60 days Reac ELISA and Reac F29 | | OG001 | Nifurtimox 60 Days Reactive and Non-reactive | Nifurtimox 60 days with Reac ELISA and Nonreac F29 | | OG002 | Nifurtimox 60 Days Non-reactive and Reactive | Nifurtimox 60 days with Nonreac ELISA and Reac F29 | | OG003 | Nifurtimox 60 Days Non-reactive and Non-reactive | Nifurtimox 60 days Nonreac ELISA and Nonreac F29 | | OG004 | Nifurtimox 30 Days Reactive and Reactive |
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| Other Pre-specified | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Sero-reduction is defined as a => 20% reduction in optical density [OD]) using two conventional ELISA serology tests in subjects => 8 months to < 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects => 8 months to < 18 years of age at randomization; or reactive results in subjects < 8 months of age at randomization. Non-reactive ELISA = Nonreac ELISA Non-reactive IHA = Nonreac IHA Reactive IHA decrease = Reac IHA dec React IHA nochange = Reac IHA nochange Reactive ELISA: seroreduction = Reac ELISA reduc Reactive ELISA: others = Reac ELISA other | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Non-reactive ELISA and Non-reactive IHA | Nonreac ELISA and Nonreac IHA | | OG001 | Non-reactive ELISA and Reactive IHA Decrease | Nonreac ELISA and Reac IHA dec | | OG002 | Non-react ELISA and React IHA Nochange | Nonreac ELISA and Reac IHA nochange | | OG003 | Reactive ELISA: Sero-reduction and Non-react IHA |
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| Other Pre-specified | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Cure is defined as sero-reduction (in subjects => 8 months to < 18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a => 20% reduction in optical density [OD]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G [IgG] concentration measured by two conventional ELISA serology tests. Cure = Cure Non reactive/reactive decreasing = Nonreac/reac dec Reactive non-decreasing = Reac nondec No cure = No Cure Missing IHA testing = IHA missing | | Posted | | Count of Participants | | Participants | | Up to 420 days (Visit 11 post-treatment) | | | | ID | Title | Description |
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| OG000 | Cure and Non Reactive/Reactive Decreasing | ELISA Cure and IHA Nonreac/reac dec | | OG001 | Cure and Reactive Non-decreasing | ELISA Cure and IHA Reac nondec | | OG002 | No Cure and Non Reactive/Reactive Decreasing | ELISA No Cure and IHA results: Nonreac/reac dec | | OG003 | No Cure and Reactive Non-decreasing |
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