Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT01111305
Eligibility Criteria:
* INCLUSION CRITERIA: (Screening)
A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:
1. Between 18 and 65 years of age
2. Residence in or travel to a Loa-endemic region for greater than 1 month
EXCLUSION CRITERIA: (Screening)
A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:
1. Known to be pregnant
2. Known to be HIV-positive
INCLUSION CRITERIA: (Interventional Study)
A subject will be eligible for participation in the interventional portion of the study only if all of the following criteria apply:
1. The subject has documented loiasis with 0-5000 microfilariae/mL blood.
2. The subject agrees to storage of samples for study
3. A female subject is eligible for this study if she is any of the following:
* Not pregnant or breast-feeding.
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
* Of childbearing potential but agrees to practice effective contraception\* or abstinence for 3 months after administration of the investigational study drug (reslizumab or placebo)
* NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female subject s entry into the study and is the sole sexual partner for the female subject; 2) implants of levonorgestrel; 3) injectable progestogen, an intrauterine device with a documented failure rate of less than 1percent; 4) oral contraceptives; and 5) double barrier methods including diaphragm or condom with a spermicide.
EXCLUSION CRITERIA: (Interventional Study)
A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:
1. The subject tests positive for HIV infection or has any other known immunodeficiency.
2. The subject has a concomitant active infection with Onchocerca volvulus.
3. The subject has used any other investigational agent within the past 30 days.
4. The subject has used immunosuppressive agents (as listed in section 8.1) within the past 30 days.
5. The subject has a history of allergic reaction to any antibody therapy or to DEC.
6. The subject has chronic kidney or liver disease.
7. The subject has any condition that, in the Investigator s opinion, places the subject at undue risk by participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01111305
Study Brief:
Protocol Section:
NCT01111305