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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00621894
Eligibility Criteria:
Inclusion Criteria:
* Adults 18 years or older
* Diagnosis of ITP for at least 3 months consistent with ASH guidelines
* Treated with one or more prior therapies for ITP and platelet counts \< 30,000/µL or \< 50,000/µL if on a stable oral corticosteroid for ≥ 4 weeks, supported by 2 platelet counts in prior 30 days
* Laboratory results within normal range except for the following analytes
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil counts \> 1000/mL
* ALT ≤ 1.5X ULN
* AST ≤ 1.5X ULN
* Creatinine \< 1.5X ULN
* Bilirubin \< 1.5X ULN
* BUN \< 1.5X ULN
* PT \< 1.5X ULN
* aPTT \<1.5X ULN
* Women of child-bearing potential must have a negative serum pregnancy test within 4 days prior to the first dose of study treatment and agree to practice an approved method of contraception or abstinence from sexual intercourse.
* Willing to sign a written informed consent
Exclusion criteria:
* History of heart attack or cardiovascular disease
* Known history of arterial or venous thrombosis
* More than 3 risk factors for thromboembolic events (diabetes, smoker, using oral contraception, using estrogen therapy, hypertriglyceridemia, average cholesterol \> 240 mg/dL, treatment for hypertension)
* Active cancer or a history of bone marrow disorders
* Women who are pregnant or nursing
* History of alcohol/drug abuse or dependence within one year
* Listed medications dosed within:
* 4 weeks of the first dose of the study treatment:
* Use of Rituximab
* Use of cytotoxic agents
* Use of Cyclosporine and other immunomodulators
* Use of an investigational drug
* 2 weeks of the first dose of the study treatment:
* Use of Danazol
* Use of Azathioprine
* Use of Mycophenolate mofetil and pulsed-dose steroids
* 1 week of the first dose of the study treatment:
* Use of Anti-D (WinRho®)
* Use of IVIG
* Had a platelet transfusion
* Use of herbal/dietary supplements (excluding vitamins and mineral supplements)
* 3 days of the first dose of the study treatment
* Use of aspirin, aspirin containing compounds
* salicylates
* milk of magnesia
* non-steroidal anti-inflammatory drugs (unless prescribed for heart disease)
* History of platelet aggregation that would prevent measurement of platelet counts
* Known active infection with HIV, hepatitis B, or hepatitis C
* In the Investigator's opinion, the patient is not able to comply with requirements of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00621894
Study Brief:
Protocol Section:
NCT00621894