Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
- Registration Number
- NCT02868060
- Lead Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
- Brief Summary
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mcg/kg AMG531 Romiplostim The administration of Romiplostim will be performed on Day 1 and 8 3 mcg/kg AMG531 Romiplostim The administration of Romiplostim will be performed on Day 1 and 8
- Primary Outcome Measures
Name Time Method The incidence of all adverse events including evaluation of antidrug antibody status Up to 43 days after dosing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Wuxi People's Hospital
🇨🇳Wuxi, China
Peking Union hospital
🇨🇳Beijing, China
West China hospital
🇨🇳Chengdu, China
Chinese academy of medical science hematology hospital
🇨🇳Tianjin, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China