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临床试验/EUCTR2017-001773-17-BE
EUCTR2017-001773-17-BE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)

FibroGen, Inc.0 个研究点目标入组 303 人开始时间: 2017年8月18日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
303
研究概览入排标准研究者记录与标识符相似试验

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.
  • •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 > 400 mIU/mL
  • •Patients with elevated serum erythropoietin levels (>400 mIU/mL) are allowed to repeat after = 7 days. If the serum erythropoietin remains elevated (>400 mIU/mL) the patient may then qualify for the OL Higherythropoietin cohort.
  • •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. Exclusion criteria 15 has been removed
  • •16. 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
  • •17. Clinically significant or uncontrolled ongoing inflammatory/autoimmune disease (e.g., rheumatoid arthritis, Crohn’s disease, celiac disease, etc.)
  • •18. History of significant liver disease or active liver disease
  • •19. Major surgery planned during the treatment period
  • •20. Known, active or chronic gastrointestinal bleeding
  • •21. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
  • •22. 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
  • •23. 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
  • •24. Previous recipient of roxadustat or another hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  • •25. 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

研究者

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