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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT00718692
Eligibility Criteria:
Inclusion Criteria:
* Confirmed presence of thrombocytopenia with platelet count \< 30,000/mm3 at the pre-dose visit.
* History of isolated ITP
* RhD-positive serology.
* Previous treatment and response to first line therapy for ITP
Exclusion Criteria:
* Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
* Suspected infection with HIV, Hepatitis C, H. pylori.
* Clinical splenomegaly
* History of abnormal bone marrow examination.
* Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
* Underlying haemolytic condition
* History of splenectomy.
* Subject is pregnant, breast feeding or intends to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00718692
Study Brief:
Protocol Section:
NCT00718692