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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00372892
Eligibility Criteria:
Inclusion Criteria:
* Non-splenectomized patients with acute ITP, where "acute ITP" is defined as a platelet count below 30 at the time that standard treatment was recommended by a physician and for which no treatment had been received for the preceding 30 days.
* Must be receiving standard ITP treatment.
Exclusion Criteria:
* Cardiac arrhythmia.
* Uncontrolled hypertension or inability to hold antihypertensive medications for 12 hours prior to and throughout study drug infusions.
* Known coronary artery disease, angina pectoris or myocardial infarction within the last year.
* Significant pulmonary disease within the last year.
* Stroke, transient ischemic attack or venous thrombosis within the last year.
* Secondary causes of thrombocytopenia (splenomegaly \[palpable spleen or radiologically confirmed \>14 cm\], drug-induced thrombocytopenia, hereditary thrombocytopenia, microangiopathic hemolytic anemia, myelodysplastic syndrome).
* Chronic lymphocytic leukemia or lymphoma.
* Active or metastatic cancer.
* History of hepatitis B or C or HIV.
* Active infection in the 4 weeks before randomization.
* Inherited coagulation factor deficiency.
* Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS) medications, clopidogrel or ticlopidine in the 7 days preceding study drug infusions; vitamin K antagonists (warfarin) in the 3 days preceding study drug infusions; unfractionated heparin or low molecular weight heparin in the 24 hours preceding study drug infusions.
* Elevated INR or prolonged PTT; LDH, serum creatinine, liver function tests (AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin) increased more than 1.5 times upper limit of normal.
* Prior rituximab treatment.
* Unable to schedule 4 weekly study infusions.
* Pregnancy or breastfeeding.
* Known sensitivity to murine proteins, Chinese Hamster Ovary (CHO) cell proteins or to any component of rituximab.
* Participation in another clinical trial.
* Geographic inaccessibility.
* Failure to provide written informed consent.
* Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00372892
Study Brief:
Protocol Section:
NCT00372892