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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00225394
Eligibility Criteria:
Inclusion Criteria:
1\) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported.
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Exclusion Criteria:
1. Patients receiving systemic therapy for acute opportunistic infection at time of enrollment
2. Patients receiving investigational drugs
3. Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers
4. Patients with active substance abuse or other condition that would impair compliance
5. Patients who are unable to give informed consent
6. Any patient with a creatinine clearance \< 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (\>40) as would occur with resolving ATN.
7. Persistent ANC \< 1,000 for 2 consecutive weeks despite treatment with G-CSF
8. Any female patient who plans to become pregnant within one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00225394
Study Brief:
Protocol Section:
NCT00225394