- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619097
Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes
November 29, 2015 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.
The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The study started from the lowest dose, 0.08mg/kg, each group will enroll 4 to 6 subjects.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhijian Xiao, Doctor
- Phone Number: +86-022-23909184
- Email: zjxiao@medmail.com.cn
Study Contact Backup
- Name: Fengkui Zhang, Doctor
- Phone Number: +86-022-23909229
Study Locations
-
-
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Tianjin, China, 300020
- Recruiting
- Hospital of Blood Diseases, Chinese Academy of Medical Sciences
-
Principal Investigator:
- Fengkui Zhang
-
Principal Investigator:
- Zhijian Xiao
-
Contact:
- Zhijian Xiao, Doctor
- Email: zjxiao@medmail.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women ≥18 years, premenopausal women must have negative pregnancy test.
- 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-.
- 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.
- Never with erythropoietin agents treatment prior to enrollment.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1 during screening.
- Hemoglobin ≥7g/dL and ≤10g/dL, at least two detections during screening.
- Adequate transferrin saturation (≥15%), ferritin (≥12ng/mL), folate (≥ lower limits of normal), vitamin B12 (≥ lower limits of normal)
- Patients understand and are able to provide written informed consent.
Exclusion Criteria:
- Pregnant or breast feeding women or women having positive pregnant test, women or men whose spouse plan to become pregnant with 4 weeks after the end of treatment .
- Therapy-related or secondary MDS.
- Previously diagnosed with intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS).
- History of severe allergic or anaphylactic reactions or hypersensitivity to erythropoiesis-stimulating agents or polyethylene glycol.
- History of red blood cell or blood transfusion during 4 weeks prior to enrollment.
- Known other disease which can lead to anemia (including haemolytic disease and digestive tract hemorrhage).
- Uncontrolled hypertension 2 weeks prior to enrollment, defined as systolic blood pressure ≥160mmHg or diastolic blood pressure ≥ 95mmHg.
- Clinically significant systemic infection or uncontrolled chronic inflammatory disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator at screening.
- Evidence of bone marrow collagen fibrosis, biopsy argentaffin staining showed reticular fiber ≥++.
- History of deep venous thrombosis or arterial embolism within 12 months prior to enrollment.
- 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.
- Any serious medical condition, lab abnormality or psychiatric illness within 6 months prior to enrollment.
- History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma.
- Estimated survival time < 6 months.
- Plan to get major surgery which will lead to massive bleeding during the study.
- Treatment with any other investigational drug within 6 weeks prior to enrollment, or plan to participate in any other investigational drug during the study.
- Any other condition not specifically noted above which, in the judgement of the investigator, would preclude the patient from participating in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.08mg/kg
Pegol-sihematide injection, 0.08mg/kg, single-dose
|
single dose
Other Names:
|
Experimental: 0.2mg/kg
Pegol-sihematide injection, 0.2mg/kg, single-dose
|
single dose
Other Names:
|
Experimental: 0.33mg/kg
Pegol-sihematide injection, 0.33mg/kg, single-dose
|
single dose
Other Names:
|
Experimental: 0.5mg/kg
Pegol-sihematide injection, 0.5mg/kg, single-dose
|
single dose
Other Names:
|
Experimental: 0.7mg/kg
Pegol-sihematide injection, 0.7mg/kg, single-dose
|
single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 28 days after injection
|
28 days after injection
|
Maximum Plasma Concentration [Cmax]
Time Frame: 10min before injection to 336h after injection
|
10min before injection to 336h after injection
|
Time to Maximum Plasma Concentration [Tmax]
Time Frame: 10min before injection to 336h after injection
|
10min before injection to 336h after injection
|
Half-life [t1/2]
Time Frame: 10min before injection to 336h after injection
|
10min before injection to 336h after injection
|
Area Under the Curve [AUC]).
Time Frame: 10min before injection to 336h after injection
|
10min before injection to 336h after injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The changes of hemoglobin (g/L) after treatment
Time Frame: From date of recruitment until the date of biggest documented progression up to 28 weeks
|
From date of recruitment until the date of biggest documented progression up to 28 weeks
|
The changes of reticulocyte (10^9/L) after treatment
Time Frame: From date of recruitment until the date of biggest documented progression up to 28 weeks
|
From date of recruitment until the date of biggest documented progression up to 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zhijian Xiao, Doctor, Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
November 20, 2015
First Submitted That Met QC Criteria
November 29, 2015
First Posted (Estimate)
December 2, 2015
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 29, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-EPOP1b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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