Trial · NCT02625974
A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
NCT02625974, Phase 3, Completed, Bayer; results first posted 2019-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi. Trials, record NCT02625974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02625974
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
- NCT number
- NCT02625974
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Chagas Disease
- Interventions
- Nifurtimox (Lampit, BAYA2502), Placebo
- First posted
- 2015-12-09
- Last updated
- 2024-08-19
- Other registries' IDs
- eudract:2022-001504-17
- Results first posted
- 2019-10-29
- Limitations and caveats
- Abnormal findings on neurological examination by physical examination after Screening will be documented as AEs.
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | At 12 months post-treatment | Percentage of subjects | NUMBER | |
| 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 | Participants | NUMBER | |
| 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 | ug/L | MEDIAN | |
| 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 | ug/L | MEDIAN | |
| 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 | ug/L | MEDIAN | |
| 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 | ug/L | MEDIAN | |
| 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 | Participants | NUMBER | |
| 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 | Participants | NUMBER | |
| 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 | Participants | NUMBER | |
| 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 | Optical density | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group603
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | Nifurtimox 60 Days / Arm 1 | 32.9 | 95% Confidence Interval 26.4 to 39.3 | Percentage of subjects | |
| Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 18.9 | 95% Confidence Interval 11.2 to 26.7 | Percentage of subjects | |
| Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen. | Nifurtimox 60 Days / Arm 1 | 16 | Participants | ||
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 60 Days / Arm 1 | Predose | NA | Full Range NA to 26.8 | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Predose | NA | Full Range NA to NA | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 60 Days / Arm 1 | 5 - 10 MIN POST | NA | Full Range NA to 154.8 | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 5 - 10 MIN POST | 21.1 | Full Range NA to 695.0 | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 60 Days / Arm 1 | 10 - 120 MIN POST | 78.2 | Full Range 5.8 to 847.5 | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 10 - 120 MIN POST | 49.0 | Full Range NA to 524.3 | ug/L |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Nifurtimox 60 Days / Arm 1 | 2 - 4 HOURS POST | 215.4 | Full Range 77.9 to 516.3 | ug/L |
1 to 10 of 603Source ClinicalTrials.gov
See all 603 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Nifurtimox 60 Days / Arm 1 | 219 | |
| Part 1 | STARTED | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 111 | |
| Part 1 | Received Treatment | Nifurtimox 60 Days / Arm 1 | 219 | |
| Part 1 | Received Treatment | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 111 | |
| Part 1 | COMPLETED | Nifurtimox 60 Days / Arm 1 | 210 | |
| Part 1 | COMPLETED | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 108 | |
| Part 1 | NOT COMPLETED | Nifurtimox 60 Days / Arm 1 | 9 | |
| Part 1 | NOT COMPLETED | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 3 | |
| Part 2 | STARTED | Nifurtimox 60 Days / Arm 1 | 197 | |
| Part 2 | STARTED | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | 98 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Nifurtimox 60-day Regimen | 19 | 219 | 27 |
| other | Abdominal pain | Gastrointestinal disorders | Nifurtimox 30-day Regimen | 9 | 111 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Nifurtimox 60-day Regimen | 15 | 219 | 20 |
| other | Abdominal pain upper | Gastrointestinal disorders | Nifurtimox 30-day Regimen | 4 | 111 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Nifurtimox 60-day Regimen | 16 | 219 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Nifurtimox 30-day Regimen | 6 | 111 | 7 |
| other | Nausea | Gastrointestinal disorders | Nifurtimox 60-day Regimen | 19 | 219 | 24 |
| other | Nausea | Gastrointestinal disorders | Nifurtimox 30-day Regimen | 14 | 111 | 15 |
| other | Vomiting | Gastrointestinal disorders | Nifurtimox 60-day Regimen | 33 | 219 | 57 |
| other | Vomiting | Gastrointestinal disorders | Nifurtimox 30-day Regimen | 10 | 111 | 11 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nifurtimox 60-day Regimen | 0 | 219 |
| Total, all-cause mortality | Nifurtimox 30-day Regimen | 0 | 111 |
| Total, other adverse events | Nifurtimox 60-day Regimen | 128 | 219 |
| Total, other adverse events | Nifurtimox 30-day Regimen | 51 | 111 |
| Total, serious adverse events | Nifurtimox 60-day Regimen | 6 | 219 |
| Total, serious adverse events | Nifurtimox 30-day Regimen | 3 | 111 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs) | Trial comparisons |
| Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators | Trial comparisons |
| Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | Trial comparisons |
| Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | Trial comparisons |
| Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | Trial comparisons |
| Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2: Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | Trial comparisons |
| Nifurtimox 60-day Regimen vs Nifurtimox 30-day Regimen: deaths from any cause | Trial comparisons |
| Nifurtimox 60-day Regimen vs Nifurtimox 30-day Regimen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02625974
GET https://conductscience.org/api/trials/v1/NCT02625974/registered?page=2