Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02868099
Other study ID # 531-CN002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2015
Est. completion date June 2017

Study information

Verified date April 2024
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date June 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Romiplostim

Placebo


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Kirin China Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of weeks in which the platelet response counts increase above 50×10^9/L 6 weeks
Secondary Proportion of subjects whose platelet counts relative to the baseline increase = 20×10^9/L 6 weeks
Secondary Proportion of subjects who have received emergency treatment to increase the platelet counts 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Not yet recruiting NCT05562882 - A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia Early Phase 1