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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT07133659
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged ≥18 years.
2. Diagnosis of primary ITP and having a platelet count of \< 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects.
3. Clinical need for second (subsequent) line treatment with a platelet elevating therapy assessed by the physician in charge.
4. Signed and dated written informed consent.
Exclusion Criteria:
1. Previous treatment with TPO-RA.
2. Pregnancy or lactation.
3. Patients with active serious bleeding or at high risk of bleeding as judged by physician in charge.
4. Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) during treatment with Avatrombopag.
5. Secondary ITP defined as ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders Systemic Lupus Erythematosus or Antiphospholipid Syndrome; ITP secondary to Common Variable Immune Deficiency; ITP secondary to the following viral infections eg Human Immunodeficiency Virus.
6. Concomitant autoimmune hemolytic anemia, Evans syndrome.
7. Presence of any serious comorbidity where the condition may worsen the study drugs.
8. Presence of active malignancy unless deemed cured by adequate treatment. Participants with the following neoplastic conditions can be included:
* Monoclonal gammopathy of undetermined significance (MGUS) or monoclonal B lymphocytosis of undetermined significance (MBUS)
* Basal/squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Carcinoma in situ of the breast
* Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
9. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07133659
Study Brief:
Protocol Section:
NCT07133659