Trial · NCT02625974
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | At 12 months post-treatment | 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. |
| Primary | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen. | 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 | 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. |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | The evaluation was based on clinical examinations. Measured in sub-population. |
| Secondary | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Secondary | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen | 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 | 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. |
| Secondary | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | 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 | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total |
| Secondary | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | 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 | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total |
| Secondary | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | 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 | 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. |
| Secondary | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | 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 | 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. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | At Visit 1 (before treatment started) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Up to 7 days (Visit 3) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Up to 30 days (Visit 6) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Up to 60 days (Visit 8; end of treatment) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | Up to 90 days (Visit 9 post-treatment) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | Up to 240 days (Visit 10 post-treatment) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | Up to 420 days (Visit 11 post-treatment) | The evaluation was based on clinical examinations. |
| Secondary | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Up to 90 days (Visit 9 post-treatment) | |
| Secondary | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Up to 420 days (Visit 11 post-treatment) | The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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