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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT00162006
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 and \<= 65 years
* ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
* Baseline platelet count of \<= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
* No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
* For females of child bearing potential, use of adequate birth control measures during study participation
* Written informed consent
Exclusion Criteria:
* Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
* Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
* Underlying other autoimmune or lymphoproliferative disorder
* Uncontrolled hypertension
* Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
* Malignancy or history of malignancy
* Documented selective IgA deficiency (\<= 10 mg/dL)
* Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
* History of severe adverse reactions to blood and/or blood products
* Pregnancy or lactation
* Positivity for HIV, or HCV antibodies, or HBsAg
* History of unresponsiveness to IVIG defined as a peak increment in platelet count \<= 20,000/µL coincident with the last IVIG treatment course prior to study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00162006
Study Brief:
Protocol Section:
NCT00162006