Back to resultsEvaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Primary Purpose
Immune Thrombocytopenia (ITP)
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Romiplostim
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia (ITP)
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
- Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
- Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
- The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.
Exclusion Criteria:
- Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
- Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
- Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
- Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
- Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
- Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
- Pregnant or breast feeding.
- In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
Sites / Locations
- Peking Union hospital
- West China hospital
- Chinese academy of medical science hematology hospital
- Wuxi People's Hospital
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 mcg/kg AMG531
3 mcg/kg AMG531
Arm Description
The administration of Romiplostim will be performed on Day 1 and 8
The administration of Romiplostim will be performed on Day 1 and 8
Outcomes
Primary Outcome Measures
The incidence of all adverse events including evaluation of antidrug antibody status
Secondary Outcome Measures
Full Information
NCT ID
NCT02868060
First Posted
August 11, 2016
Last Updated
October 11, 2017
Sponsor
Kyowa Kirin China Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02868060
Brief Title
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Official Title
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin China Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia (ITP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 mcg/kg AMG531
Arm Type
Experimental
Arm Description
The administration of Romiplostim will be performed on Day 1 and 8
Arm Title
3 mcg/kg AMG531
Arm Type
Experimental
Arm Description
The administration of Romiplostim will be performed on Day 1 and 8
Intervention Type
Drug
Intervention Name(s)
Romiplostim
Other Intervention Name(s)
AMG531
Primary Outcome Measure Information:
Title
The incidence of all adverse events including evaluation of antidrug antibody status
Time Frame
Up to 43 days after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.
Exclusion Criteria:
Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
Pregnant or breast feeding.
In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinese academy of medical science hematology hospital
Organizational Affiliation
Chinese academy of medical science hematology hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union hospital
City
Beijing
Country
China
Facility Name
West China hospital
City
Chengdu
Country
China
Facility Name
Chinese academy of medical science hematology hospital
City
Tianjin
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34921514
Citation
Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clin Pharmacol Drug Dev. 2022 Mar;11(3):379-387. doi: 10.1002/cpdd.1059. Epub 2021 Dec 17.
Results Reference
derived
Learn more about this trial
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
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