Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
- Registration Number
- NCT02868099
- Lead Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
- Brief Summary
The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
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 while signing the ICF.
- Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have no response or relapse to at least 1 prior treatment for immune thrombocytopenia (ITP).
- 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 those typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, and no treatment or active disease within 5 years prior to signing the ICF..
- 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 myeloproliferative leukemia (MPL) stimulation product other than the subject who had suspended recombinant human thrombopoietin (rHuTPO) for injection for 4 weeks before signing 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 prior to signing the ICF.
- Pregnant or breastfeeding.
- 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 Drug Romiplostim Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week Placebo Placebo Subjects received placebo for injection treatment will be administered subcutaneously once a week
- Primary Outcome Measures
Name Time Method Number of weeks in which the platelet response counts increase above 50×10^9/L 6 weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L 6 weeks Proportion of subjects who have received emergency treatment to increase the platelet counts 6 weeks
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China