Phase 2
Completed N=120
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Source: ClinicalTrials.gov NCT01377480 ↗Enrolled (actual)
120
Serious AEs
5.8%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction — 15.6; 10.0; 82.1; 86.7 Percentage of participants
Summary
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction |
15.6; 10.0; 82.1; 86.7 | — |
Eligibility Criteria
Inclusion Criteria
- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)
- Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
- Must have a normal 12-lead electrocardiogram (ECG)
- Must have a normal 2-D echocardiogram
- Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
- Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
- Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug
Exclusion Criteria
- Are breastfeeding, pregnant, or planning to become pregnant
- Body weight 2.5 mg/dL or 200 micromoles at Screening
- Has a history of severe alcohol abuse within two years from Screening
- Is taking any of the prohibited medication
Data sourced from ClinicalTrials.gov (NCT01377480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.