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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03718533
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent form before any study assessment is performed
2. Male of female patients ≥ 18 years of age
3. Patients diagnosed with primary or secondary poor graft function (PGF) defined as two or more cytopenias after day +30 post-transplant (re-tested in a peripheral blood analysis at screening):
1. Platelet count \<20,000/ µL (mandatory)
2. Absolute neutrophil count (ANC) \<1,000/µL
3. Hemoglobin \<100 g/L
4. Presence of donor chimerism \>90% in screening visit
5. Karnofsky status ≥90% (Karnofsky assessment must be performed within 7 days prior to Day 1)
Exclusion Criteria:
1. Pregnant or nursing (lactating women).
2. Evidence of active acute or chronic graft versus host disease (GVHD).
3. Evidence of any active malignancy.
4. Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive in screening visit.
5. Cytogenetic abnormality in chromosome 7 present before the allo-HSC.
6. Evidence of any clonal abnormality on cytogenetics (in bone marrow analysis).
* A local post-transplant conventional cytogenetic assessment should be available within 8 weeks before Day 1.
* If the cytogenetics is not valuable, i.e, it does not show metaphases, a FISH for MDS-related most frequent abnormalities including chromosome 7 is accepted.
As a consequence, patients with dry tap bone marrow aspiration are NOT eligible.
7. Evidence of bone marrow involvement or progression of the underlying disease assessed by the applicable methods in each case.
8. Evidence of thrombotic microangiopathy.
9. Evidence of possible causes of cytopenia other than PGF (active infections, myelotoxic drugs, hypersplenism…).
10. Prior use of any thrombopoietin receptor (TPO-R) agonists for PGF.
11. AST or ALT levels \>3 x ULN.
12. Creatinine level ≥1.5 x ULN.
13. Total bilirubin level ≥1.5 x ULN.
14. Previous thromboembolic event (other than line-related upper extremity thrombosis)
15. Hypersensitivity to eltrombopag or its components.
16. Clinically significant ECG abnormality history or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study such as uncontrolled or significant cardiac disease or impaired cardiac function including any of the following:
1. . Corrected QTc \> 450 msec (male subjects), \> 460 msec (female subjects) using Fredericia correction (QTcF) on the screening ECG
2. . Myocardial infarction
3. . Uncontrolled congestive heart failure
4. . Unstable angina
5. . Congenital long QT syndrome.
17. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
18. Patient with liver cirrhosis.
19. Risk factors for Torsade de Pointes including uncorrected hypokalemia or hypomagnesemia.
20. Subjects with any serious and/ or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with patient´s safety, obtaining informed consent or compliance with the study procedures as per investigator discretion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03718533
Study Brief:
Protocol Section:
NCT03718533