Myelodysplastic SyndromesPhase 1NCT02619097
Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes
A Phase 1 study testing Pegol-sihematide injection in people with Myelodysplastic Syndromes and Anemia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Anemia
- What is being tested?
- Pegol-sihematide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Fengkui Zhang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, 300020
Zhijian Xiao, Doctor, zjxiao@medmail.com.cn
Zhijian Xiao
About this study
The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.
Read the detailed description
The study started from the lowest dose, 0.08mg/kg, each group will enroll 4 to 6 subjects.
- Conditions
- Myelodysplastic Syndromes, Anemia
- Being tested
- Pegol-sihematide injection
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegol-sihematide injectionDrug
Also called EPO-018B
single dose
| Study group | Role | What they receive |
|---|---|---|
| 0.08mg/kg | Experimental | Pegol-sihematide injection, 0.08mg/kg, single-dose Receives: Drug: Pegol-sihematide injection |
| 0.2mg/kg | Experimental | Pegol-sihematide injection, 0.2mg/kg, single-dose Receives: Drug: Pegol-sihematide injection |
| 0.33mg/kg | Experimental | Pegol-sihematide injection, 0.33mg/kg, single-dose Receives: Drug: Pegol-sihematide injection |
| 0.5mg/kg | Experimental | Pegol-sihematide injection, 0.5mg/kg, single-dose Receives: Drug: Pegol-sihematide injection |
| 0.7mg/kg | Experimental | Pegol-sihematide injection, 0.7mg/kg, single-dose Receives: Drug: Pegol-sihematide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 28 days after injection
Maximum Plasma Concentration [Cmax]
Measured: 10min before injection to 336h after injection
Time to Maximum Plasma Concentration [Tmax]
Measured: 10min before injection to 336h after injection
Half-life [t1/2]
Measured: 10min before injection to 336h after injection
Area Under the Curve [AUC]).
Measured: 10min before injection to 336h after injection
Secondary outcomes (2)
The changes of hemoglobin (g/L) after treatment
Measured: From date of recruitment until the date of biggest documented progression up to 28 weeks
The changes of reticulocyte (10^9/L) after treatment
Measured: From date of recruitment until the date of biggest documented progression up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhijian Xiao, Doctor, Study chair, Hospital of Blood Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619097
- Sponsor's protocol ID
- HS-EPOP1b
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT02619097
- Acronym / sponsor ID
- HS-EPOP1b
- Conditions
- Myelodysplastic Syndromes, Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.
Detailed description
The study started from the lowest dose, 0.08mg/kg, each group will enroll 4 to 6 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.08mg/kg | Experimental | Drug: Pegol-sihematide injectionPegol-sihematide injection, 0.08mg/kg, single-dose |
| 0.2mg/kg | Experimental | Drug: Pegol-sihematide injectionPegol-sihematide injection, 0.2mg/kg, single-dose |
| 0.33mg/kg | Experimental | Drug: Pegol-sihematide injectionPegol-sihematide injection, 0.33mg/kg, single-dose |
| 0.5mg/kg | Experimental | Drug: Pegol-sihematide injectionPegol-sihematide injection, 0.5mg/kg, single-dose |
| 0.7mg/kg | Experimental | Drug: Pegol-sihematide injectionPegol-sihematide injection, 0.7mg/kg, single-dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegol-sihematide injectionAlso: EPO-018Bsingle dose | Drug | 0.08mg/kg, 0.2mg/kg, 0.33mg/kg, 0.5mg/kg, 0.7mg/kg |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 28 days after injection
Maximum Plasma Concentration [Cmax]
Time frame: 10min before injection to 336h after injection
Time to Maximum Plasma Concentration [Tmax]
Time frame: 10min before injection to 336h after injection
Half-life [t1/2]
Time frame: 10min before injection to 336h after injection
Area Under the Curve [AUC]).
Time frame: 10min before injection to 336h after injection
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengkui Zhang, Doctor contact
Zhijian Xiao, Doctor study chair
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegol-sihematide injection in people with Myelodysplastic Syndromes and Anemia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijian Xiao, Doctor (+86-022-23909184, zjxiao@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 28 days after injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.