Clinical trial NCT02868099: Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, Randomized, Placebo-controlled, Double-blinded then Open-label
Primary purpose: TREATMENT

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).


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 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.

Primary outcomes:
measure: Number of weeks in which the platelet response counts increase above 50×10^9/L
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L
timeFrame: 6 weeks
measure: Proportion of subjects who have received emergency treatment to increase the platelet counts
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Peking Union Medical College Hospital,
role: PRINCIPAL_INVESTIGATOR
References: