Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes

NCT02619097 | Unknown Phase 1

• 1 other identifier: HS-EPOP1b
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndromes; Anemia

Outcome Measures

Primary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  28 days after injection

• Maximum Plasma Concentration [Cmax]

  10min before injection to 336h after injection

• Time to Maximum Plasma Concentration [Tmax]

  10min before injection to 336h after injection

• Half-life [t1/2]

  10min before injection to 336h after injection

• Area Under the Curve [AUC]).

  10min before injection to 336h after injection

Secondary Outcomes (2)

• The changes of hemoglobin (g/L) after treatment

  From date of recruitment until the date of biggest documented progression up to 28 weeks

• The changes of reticulocyte (10^9/L) after treatment

  From date of recruitment until the date of biggest documented progression up to 28 weeks

Study Arms (5)

0.08mg/kg

EXPERIMENTAL

Pegol-sihematide injection, 0.08mg/kg, single-dose

Drug: Pegol-sihematide injection

0.2mg/kg

EXPERIMENTAL

Pegol-sihematide injection, 0.2mg/kg, single-dose

Drug: Pegol-sihematide injection

0.33mg/kg

EXPERIMENTAL

Pegol-sihematide injection, 0.33mg/kg, single-dose

Drug: Pegol-sihematide injection

0.5mg/kg

EXPERIMENTAL

Pegol-sihematide injection, 0.5mg/kg, single-dose

Drug: Pegol-sihematide injection

0.7mg/kg

EXPERIMENTAL

Pegol-sihematide injection, 0.7mg/kg, single-dose

Drug: Pegol-sihematide injection

Interventions

Pegol-sihematide injection DRUG

single dose

Also known as: EPO-018B

0.08mg/kg; 0.2mg/kg; 0.33mg/kg; 0.5mg/kg; 0.7mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhijian Xiao, Doctor

  Hospital of Blood Diseases, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Zhijian Xiao, Doctor

CONTACT

+86-022-23909184; zjxiao@medmail.com.cn

Fengkui Zhang, Doctor

CONTACT

+86-022-23909229

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 2, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CN (1)