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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00547066
Eligibility Criteria:
Inclusion Criteria:
* Male or female, \>18 years old, with or without prior splenectomy
* Signed written informed consent obtained prior to study entry
* ITP according to ASH guidelines, with other potential causes of thrombocytopenia excluded
* Platelet levels \< 150 x 109/L for more than 6 months
* Received an adequate course of at least one standard ITP treatment (an inadequate course of standard ITP therapy does not qualify as meeting this requirement)
* Platelet count \< 30 x 109/L at study entry and on at least one other occasion at least 1 week apart within the past month. (Phase I only: platelet count also \> 10 x 109/L at study entry).
* Bleeding assessment score of Grade 0 or 1. See full protocol for all inclusion criteria
Exclusion Criteria:
See full protocol for exclusion criteria or contact study staff for details
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00547066
Study Brief:
Protocol Section:
NCT00547066