Phase 2 Study of Posaconazole in Chagas Disease
- Conditions
- Chronic Chagas DiseaseMedDRA version: 16.0Level: LLTClassification code 10066500Term: Chagas disease recurrentSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Parasitic Diseases [C03]
- Registration Number
- EUCTR2013-000161-36-ES
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1. Each subject must be 18 to < or = to 50 years of age, of either sex and of any race, weighting > or = to 60 kg, and willing to adhere to visit schedule and study procedures.
2. Each subject must have a positive serology result for T. cruzi on any 2 of 3 of the following tests: IFA, IHA, or ELISA (testing results within the past 10 years).
3. Each subject must have a positive qualitative PCR for T. cruzi.
4. Each subject must have a normal 12-lead ECG, or it must be clinically insignificant.
5. Each subject must have a normal 2-D echocardiogram, or it must be clinically insignificant.
6. Each subject must have no evidence of ventricular tachycardia on a 24-hr Holter monitoring.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject must not weigh less than 60 kg.
2. Female subjects must not be breastfeeding, pregnant, or planning pregnancy.
3. Subjects must not be immunodeficient or immunosuppressed.
4. Subjects must not have a history of megacolon with obstipation or megaesophagus with severe swallowing impairment.
5. Subjects must not have previously received benznidazole or nifurtimox.
6. Subjects must not be a family member of a participating subject, or reside in the same household as a participating subject.
7. Subjects must not have AST or ALT levels greater than 2.5 times ULN at screening.
8. Subjects must not have serum creatinine >2.5 mg/dL or 200 micromoles at screening.
9. Subjects must not have a history of severe alcohol abuse within 2 years from screening.
10. Subjects must not be taking any prohibited medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is to evaluate efficacy of Posaconazole versus placebo in reducing parasitemia measured by qualitative PCR at end of 120 days of follow-up post treatment..;Secondary Objective: Secondary objectives include evaluation of safety and tolerability of posaconazole versus placebo, evaluation of relative efficacy and safety of posaconazole versus benznidazole, and evaluation of relative efficacy and safety of benznidazole versus placebo;Primary end point(s): The primary efficacy endpoint is the proportion of subjects who show a successful response for the posaconazole versus placebo comparison. A successful response is defined as both a negative qualitative PCR on Day 180, and a negative qualitative PCR on at least the two preceding samples.;Timepoint(s) of evaluation of this end point: Day 180 (or Day 150 if Day 180 is missing) and Day 120 and 150 (or Day 90 and 120 if Day 180 is missing).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoints are the proportion of subjects who show a successful response for the other possible pairwise comparisons with the trial (i.e., posaconazole versus benznidazole, benznidazole versus placebo, posaconazole + benznidazole versus posaconazole, versus benznidazole, versus placebo) and the proportion of subjects with negative qualitative PCR at each individual evaluation during the study.;Timepoint(s) of evaluation of this end point: Day 30, 60, 90, 120, 150, 180, and 360