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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02760251
Eligibility Criteria:
Inclusion Criteria:
* Informed consent as documented by signature (see informed consent form)
* Primary ITP according to the definition of Rodeghiero et al. (52) and a platelet count of \<30x109/l
* Age range: 18-45 years
* Previously treated patients, with failure or intolerance to first-line therapy, or relapse after first-line therapy, i.e. corticosteroids, intravenous immunoglobulin (IVIG), or anti-D immunoglobulins
Exclusion Criteria:
* Adults older than 45 and children younger than 18 years
* Platelet count higher than 30x109/l at time of screening
* Suspicion of secondary ITP
* Positive family history for ITP
* Presence or history of autoimmune disease as judged by the investigator
* Hepatosplenomegaly
* Presence or history of relevant hepatic disease as judged by the investigator
* Presence or history of thromboembolic disease as judged by the investigator
* Patients with splenectomy
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Lack of safe double contraception (see 7.1)
* Any vaccination 2 weeks prior start of the study
* Drugs with a known impact on the immune system or on platelet function must be recorded and an exclusion of the study should be discussed with the study center
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the study subject
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Previous treatment with romiplostim or eltrombopag
* Hypersensitivity to the active substance or to any of the excipients or to E. coli derived proteins
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02760251
Study Brief:
Protocol Section:
NCT02760251