A phase IV, open-label, single-arm, multi-center clinical study to evaluate the safety and efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura.

Alkem Laboratories Limited0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•1) Male and Female subject in between 18 to 65 years of age.
•2) Patients with chronic immune (idiopathic) thrombocytopenic purpura. per the American Society of Hematology guidelines.
•3) If subject is > 60 years of age, subject had a written bone marrow biopsy report consistent with a diagnosis of ITP.
•4) Subject had received at least 1 prior therapy for ITP.
•5)Subject with a single platelet count less than equal to 30 x 10 raise to 9/L at any time during the screening period.
•6) Subject (or legally - acceptable representative) was willing and able to
•provide written informed consent.

•1) Known hypersensitivity to romiplostim or any of its excipients.
•2) Subject had a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell
•3) Subjects with known history of congenital thrombocytopenia, systemic lupus erythematosus, Evans syndrome, autoimmune neutropenia,
•antiphospholipid antibody syndrome, positive for lupus anticoagulant, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
•4) Subjects with known history of infection with H. pylori.
•5) Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any
•platelet producing agent.
•6) Subject has a known hypersensitivity to any recombinant E coli-derived product.
•7) Subjects suffering from chronic liver disease (Child-Pugh score more than or equal to 7).
•8) Subjects with history of any thromboembolic disease.
•9) Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator.
•10) Subject is pregnant or breast feeding.
•11) Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.

发起方

Alkem Laboratories Limited