Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes
NCT ID: NCT02619097
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2014-06-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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0.08mg/kg
Pegol-sihematide injection, 0.08mg/kg, single-dose
Pegol-sihematide injection
single dose
0.2mg/kg
Pegol-sihematide injection, 0.2mg/kg, single-dose
Pegol-sihematide injection
single dose
0.33mg/kg
Pegol-sihematide injection, 0.33mg/kg, single-dose
Pegol-sihematide injection
single dose
0.5mg/kg
Pegol-sihematide injection, 0.5mg/kg, single-dose
Pegol-sihematide injection
single dose
0.7mg/kg
Pegol-sihematide injection, 0.7mg/kg, single-dose
Pegol-sihematide injection
single dose
Interventions
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Pegol-sihematide injection
single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) criteria, including refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD), MDS-U, 5q-.
3. Meets International Prognostic Scoring System (IPSS) classification of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analysis of the bone marrow during screening.
4. Never with erythropoietin agents treatment prior to enrollment.
5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 during screening.
6. Hemoglobin ≥7g/dL and ≤10g/dL, at least two detections during screening.
7. Adequate transferrin saturation (≥15%), ferritin (≥12ng/mL), folate (≥ lower limits of normal), vitamin B12 (≥ lower limits of normal)
8. Patients understand and are able to provide written informed consent.
Exclusion Criteria
2. Therapy-related or secondary MDS.
3. Previously diagnosed with intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS).
4. History of severe allergic or anaphylactic reactions or hypersensitivity to erythropoiesis-stimulating agents or polyethylene glycol.
5. History of red blood cell or blood transfusion during 4 weeks prior to enrollment.
6. Known other disease which can lead to anemia (including haemolytic disease and digestive tract hemorrhage).
7. Uncontrolled hypertension 2 weeks prior to enrollment, defined as systolic blood pressure ≥160mmHg or diastolic blood pressure ≥ 95mmHg.
8. Clinically significant systemic infection or uncontrolled chronic inflammatory disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator at screening.
9. Evidence of bone marrow collagen fibrosis, biopsy argentaffin staining showed reticular fiber ≥＋＋.
10. History of deep venous thrombosis or arterial embolism within 12 months prior to enrollment.
11. History of cardiocerebrovascular events within 6 months prior to enrollment, include local ischemia, embolism, cerebral hemorrhage, transient ischemic attack, myocardial ischemia or other arterial thrombosis.
12. Any serious medical condition, lab abnormality or psychiatric illness within 6 months prior to enrollment.
13. History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma.
14. Estimated survival time \< 6 months.
15. Plan to get major surgery which will lead to massive bleeding during the study.
16. Treatment with any other investigational drug within 6 weeks prior to enrollment, or plan to participate in any other investigational drug during the study.
17. Any other condition not specifically noted above which, in the judgement of the investigator, would preclude the patient from participating in the study.
18 Years
ALL
No
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhijian Xiao, Doctor
Role: STUDY_CHAIR
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Locations
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Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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Central Contacts
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Fengkui Zhang, Doctor
Role: CONTACT
Facility Contacts
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Other Identifiers
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HS-EPOP1b
Identifier Type: -
Identifier Source: org_study_id