Trial · NCT01489228
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 | |
| Secondary | Correlation of pharmacokinetic parameters with parasitological response, changes in biomarkers and safety outcomes | Day 8, 15, 36, 65, and at 4, 6 months and 12 months follow-up |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01489228/registered