EUCTR2017-001773-17-IT进行中（未招募）1 期
A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB) -
FIBROGE0 个研究点目标入组 303 人开始时间: 2021年6月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 303
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of primary MDS (confirmed by bone marrow aspirate and biopsy prior to treatment Day 1), classified by the IPSS-R as very low, low, or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization) and to show transfusion dependence for patients in both portions of the study.
- •2. RBC transfusion requirement of either:
- •a. 2 to 4 pRBC over the 8-weeks prior to registration/randomization,
- •b. 1 pRBC during the 8-weeks prior to registration/randomization:
- •Patients with 1 pRBC must have a documented history of requiring 1 pRBC/8-weeks in 2 consecutive periods of 8 weeks in the 16 weeks
- •preceding registration/randomization
- •(The PI and site staff will utilize their own institutional criteria for the determination of when to transfuse a patient)
- •c. Open-Label Lead-In patients only, the requirement to demonstrate transfusion dependence can also be met by a PI starting this particular patient on pRBC transfusion during the screening period.
- •3. There is no restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents (ESAs)), except that the patient must not have received any ESA within the 8 weeks prior to Day 1 registration/randomization. ESAs include but are not limited to any recombinant human erythropoietin and other drugs listed in Appendix I of the Protocol.
- •4. Hb < =10.0 g/dL during Screening period. Only 1 central laboratory value needs to meet the Hb < = 10.0 g/dL criteria
- •criteria. These values must be the Central Laboratory values. A third value may be obtained if necessary.
- •5. Age > =18 years
- •6. Body weight > = 45 kg
- •7. ECOG performance status of 0, 1 or 2 during screening
- •8. Must be capable of giving written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 243
排除标准
- •1. Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation exposure
- •2. Previous diagnosis of IPSS-R high risk or very high risk MDS
- •3. Planned myeloablative or craniospinal radiation during the study
- •4. Prior bone marrow or stem-cell transplantation (SCT)
- •5. Significant myelofibrosis (>2+ fibrosis)
- •6. MDS associated with 5q(del) cytogenetic abnormality
- •7. Screen serum erythropoietin level < = 200 mIU/mL or >400 mIU/mL
- •8. Alanine aminotransferase (ALT) > 3 x ULN, OR aspartate aminotransferase (AST) > 3 × ULN OR TBili > 1.5 × ULN
- •Patients with TBili up to 2.0 x ULN may be allowed to participate if the AST and ALT are within normal limits
- •9. Azacitidine, decitabine, thalidomide, lenalidomide, G-CSF, or luspatercept, or any investigational drugs within 8-weeks prior to Day 1
- •treatment or plans to use any of these medications during the course of clinical trial participation
- •10. Anticipated use of dapsone at any dose amount or chronic use of acetaminophen or paracetamol >2.0 g/day during the study for more than 7 days
- •11. Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or
- •hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia
- •12. Active infection(s) requiring systemic antibiotic therapy (upon treatment with antibiotic, stable asymptomatic patients may qualify to participate.)
- •13. Cockroft-Gault calculated estimated glomerular filtration rate (eGFR) <30 mL/min
- •14. Thromboembolic event such as DVT, pulmonary embolism, myocardial infarction, stroke, or TIA, within previous 6 months of randomization
- •15. Significant heart disease, including NYHA Class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or significant
- •valvular or endocardial disease that would put the patient at risk for thromboembolism
- •16. Clinically significant or uncontrolled ongoing
- •inflammatory/autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
- •17. History of significant liver disease or active liver disease
- •18. Major surgery planned during the treatment period
- •19. Known, active or chronic gastrointestinal bleeding
- •20. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
- •21. Clinically significant or uncontrolled medical condition that would affect the patient's ability to participate in the study or confound the study's efficacy or safety results
- •22. History of leukemia or other active malignancy except localized and non-metastatic squamous or basal cell carcinoma of the skin, or cervical intraepithelial neoplasm; patients with a history of cured malignancy with no evidence of recurrence for at least 3 years are eligible
- •23. Previous recipient of roxadustat or another hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
- •24. Pregnant or breastfeeding females
- •- Additional central laboratory samples may be collected via unscheduled visit to confirm eligibility, as deemed necessary by the investigator. Medical monitor should be informed.
- •-A positive Hep-C test will be confirmed via C-RNA testing; C-RNA negative patient may qualify to participate.
- •-Patients must meet all eligibility criteria prior to randomization; no waiver will be granted
研究者
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