A Study to Evaluate the Safety and Preliminary Efficacy of a Response-guided Dose Titration of KER-047 in the Treatment of Functional IDA (Iron Deficiency Anemia).
Megadott ok: Despite several attempts to recruit eligible participants and major protocol amendments to increase the recruitment rate, recruitment challenges remained. Therefore, the Sponsor has made the decision to terminate the KER047-IR-202 Study globally.
Key facts
- Where
- Jerusalem, Nahariya, Netanya és Zrifin, IzraelSee the 4 sites
- Phase
- 2. fázis
Where in Izrael
- Hadassah University Medical CenterJerusalem, IzraelNo longer taking part
- Galilee Medical CenterNahariya, IzraelNo longer taking part
- Laniado Hospital - Sanz Medical CenterNetanya, IzraelNo longer taking part
- Shamir Medical Center (Assaf Harofeh Medical Center)Zrifin, IzraelNo longer taking part
Trial details
- Who runs it
- Keros Therapeutics, Inc.
- Trial code
- NCT05927012
- Record updated
- 2023. november 24.
- Original description
This study aims to explore the safety and preliminary efficacy of a response-guided dose titration of KER-047 in the treatment of functional IDA (Iron deficiency anemia) in MDS (Myelodysplastic syndrome), MF(Myelofibrosis), and MDS/MPN (Myeloproliferative neoplasm) overlap syndromes.Read full original descriptionShow less
A Phase 2, Intrapatient Dose Titration Study of KER-047 in Participants With Functional Iron Deficiency Anemia Associated With Myelodysplastic Syndromes, Myelofibrosis, and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
This study aims to explore the safety and preliminary efficacy of a response-guided dose titration of KER-047 in the treatment of functional IDA (Iron deficiency anemia) in MDS (Myelodysplastic syndrome), MF(Myelofibrosis), and MDS/MPN (Myeloproliferative neoplasm) overlap syndromes.
Inclusion: Male or female ≥18 years of age, at the time of signing informed consent; One of the following:; 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); 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; 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: Anemia due to blood loss 28 days prior to D1; History of stroke, arterial embolism, or deep venous thrombosis within 6 months prior to D1; Active infection within 14 days of D1; History of drug or alcohol abuse, as defined by the Investigator, within the past 2 years; Known positive for human immunodeficiency virus, active infectious hepatitis B virus or active infectious hepatitis C virus; 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; Diagnosis of thalassemia, thalassemia trait, or other hemoglobinopathy.