Trial · NCT01489228
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
NCT01489228, Phase 2, Unknown, Drugs for Neglected Diseases
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease. Trials, record NCT01489228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01489228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
- NCT number
- NCT01489228
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 230 participants, estimated
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Chronic Chagas Disease, Indeterminate
- Interventions
- E1224, Benznidazole, Placebo
- First posted
- 2011-12-09
- Last updated
- 2011-12-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serial negative qualitative Polymerase Chain Reaction (PCR) results (3 negative PCR results from 3 samples to be collected over 7 days) as a measure of parasitological cure at end of treatment | Day 65 (end of treatment) | To determine whether at least one of three dosing regimens of orally administered E1224 is more efficacious than placebo in individuals with chronic indeterminate CD, by determining the number of patients who convert from positive to negative in serial, qualitative PCR test results |
| Secondary | Consistently negative serial qualitative PCR as a measure of sustained parasitological eradication | 4, 6 and 12 months follow-up | |
| Secondary | Qualitative PCR as a measure of parasite eradication | Day 8, 15, 36 , 65 and at 4, 6 and 12 months follow-up | |
| Secondary | Quantitative PCR as a measure of change in parasite load over time | Day 8, 15, 36, 65 and at 4, 6 and 12 months follow-up | |
| Secondary | Incidence of serological conversion to negative and changes in titers over time as measured by conventional and non-conventional serologies | Day 65 and at 4, 6 and 12 months after treatment | |
| Secondary | Changes in the levels of biomarkers over time: brain natriuretic peptide, troponin T, selected prothrombotic factors, lytic antibodies, apolipoprotein A1 and multiplex serodiagnostic assay | Day 36 , 65 and at 4, 6 and 12 months follow-up | |
| Secondary | Area under the plasma concentration versus time curve (AUC), Peak Plasma Concentration (Cmax), Minimum Plasma Concentration (Cmin), Clearance, Volume of Distribution , and Plasma Terminal Half-Life (t1/2) of ravuconazole and benznidazole | Day 0 (pre-dose), Day 1 (after 1st dose), Day 2, Day 3, steady-state phase (D8-D50), at the end of treatment (D65) and at the 4 months follow-up visit | Samples for population pharmacokinetics parameters of ravuconazole and benznidazole will be collected at randomly selected time points on Days 1, 2 and 3. |
| Secondary | Incidence and severity of adverse events (clinical and laboratory) | Up to 12 months follow-up | |
| Secondary | Incidence of Serious Adverse Events and/or adverse events leading to treatment discontinuation | Up to 12 months follow-up | |
| Secondary | Early and late predictors of sustainable response to treatments | Up to 12 months follow-up |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01489228
GET https://conductscience.org/api/trials/v1/NCT01489228/registered