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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT05927012
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥18 years of age, at the time of signing informed consent.
* One of the following:
1. Diagnosis of MDS according to the 2016 World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease with bone marrow blast percentage \<5% within 6 months prior to Day 1 (D1).
2. Diagnosis of primary myelofibrosis, post polycythemia vera MF, or post-essential thrombocytopenia MF according to the 2017 WHO criteria with bone marrow and peripheral blood blast percentage \<2%, or stable between 2% to 5% over 6 months.
3. Diagnosis of MDS/MPN overlap syndromes according to the 2016 WHO classification, with bone marrow blast percentage \<5% within 6 months prior to D1.
* Anemia with iron-restricted erythropoiesis as assessed by laboratory criteria during screening.
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
* Females of childbearing potential and sexually active males must meet the contraception requirements as outlined in the protocol.
Exclusion Criteria:
* Active infection within 14 days of D1.
* IPSS-R score indicating high or very high risk MDS, accelerated myelofibrosis (defined as \>10% blasts), or diagnosis of acute leukemia.
* Diagnosis of hemolytic anemia.
* Diagnosis of porphyria.
* Anemia due to blood loss 28 days prior to D1.
* Diagnosis of thalassemia, thalassemia trait, or other hemoglobinopathy.
* History of drug or alcohol abuse, as defined by the Investigator, within the past 2 years.
* History of stroke, arterial embolism, or deep venous thrombosis within 6 months prior to D1.
* Known positive for human immunodeficiency virus, active infectious hepatitis B virus or active infectious hepatitis C virus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05927012
Study Brief:
Protocol Section:
NCT05927012