A prospective randomized double-blind multi centre parallel arm comparative clinical study to determine the efficacy and safety of Romiplostim Biosimilar manufactured by Levim Lifetech Private Limited with Nplate manufactured by Amgen in patients with immune thrombocytopenia ITP
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- Proportion of patients achieving platelet response (i.e., greater than or equal to 50 X 10 to the power of 9 per L) for any 4 weeks of the 12 weeks of treatment with biosimilar Romiplostim treatment compared to Nplate
研究概览
简要总结
This is a prospective, randomized, double-blind, multi-centre, parallel arm clinical trial to assess the efficacy and safety of a Romiplostim Biosimilar manufactured by Levim Lifetech Private Limited compared to Nplate (Romiplostim) manufactured by Amgen in patients with immune thrombocytopenia (ITP). Conducted across 15 sites in India, the trial aims to recruit 72 subjects, with a randomization ratio of 3 is to 1 favoring the biosimilar.
The primary objective is to compare the platelet response (greater than or equal to 50 X 10 to the power of 9 per L) between both treatments over a 12-week period. Secondary objectives include analyzing safety through adverse events, measuring the presence of anti-romiplostim antibodies, and assessing pharmacokinetics. The study recognizes ITP as a rare condition with unmet medical needs, justifying the trial for its biosimilar. Each participant’s total study duration is 16 weeks, which includes 2 weeks of screening and 12 weeks of treatment. Ethical compliance will align with ICH-GCP guidelines and local regulations to ensure patient safety and data integrity throughout the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be enrolled in the study if they meet all the following criteria
- •Male and female subjects of age group 18 to 65 years (both inclusive).
- •Willing and able to provide a written informed consent.
- •Diagnosed with ITP based on the American Society of Haematology (ASH) guidelines.
- •Already received at least one prior treatment for ITP.
- •Subject greater than 60 years of age must have had a documented history of ITP with a confirmatory bone marrow report on the diagnosis.
- •Two weekly platelet count less than or equal to 30 X 10 to the power of 9 per L at any time during the screening period.
- •Haemoglobin greater than or equal to 9.0 g per decilitre
- •Patients who are willing and able to comply with all the study assessments and adhere to the protocol schedule.
排除标准
- •Subjects will be excluded from the study participation if they fall on any of the below criteria
- •Known history or presence of hypersensitivity reaction to any recombinant E.coli derived products.
- •History of haematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell carcinoma
- •Known history of congenital thrombocytopenia, thromboembolic disease, systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia, antiphospholipid antibody syndrome or positive for lupus anticoagulant or autoimmune haemolytic anaemia
- •Known history of disseminated intravascular coagulation, haemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- •Previous use of Romiplostim/ pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), TPO-RA drugs such as Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent
- •Currently receiving any treatment for ITP except corticosteroids, azathioprine, mycophenolate, cyclosporin, vincristine, and/or danazol administered at a constant dose and schedule.
- •Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc.) within 1 week before the screening Visit.
- •Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening Visit.
- •Subjects with positive laboratory findings of hepatitis B, hepatitis C, or human immunodeficiency virus at screening
- •Known history of infection with H.
- •pylori • Known case of chronic liver disease or hepatic impairment, defined as any serum bilirubin greater than or equal to 1.5 times laboratory normal range at screening
- •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 before randomization
- •Female subjects of child-bearing potential not using adequate contraceptive precautions in the judgement of the investigator
- •Breast-feeding mothers or female subjects of child-bearing potential with positive urine pregnancy test at the time of screening
- •Less than 2 months since major surgery
- •Subjects involved in clinical trials and taken investigational drugs within 30 days of enrolment
- •Creatinine clearance or calculated creatinine clearance less than 45 mL per minute (Cockcroft-Gault Equation).
结局指标
主要结局
Proportion of patients achieving platelet response (i.e., greater than or equal to 50 X 10 to the power of 9 per L) for any 4 weeks of the 12 weeks of treatment with biosimilar Romiplostim treatment compared to Nplate
时间窗: 12 weeks (Every week including baseline)
次要结局
- Proportion of patients receiving rescue medications that is Corticosteroids, IVIG, Anti D immunoglobulin, Platelet transfusions etc. during the treatment period, compared to Nplate(Number of weekly Platelet Responses defined as a platelet count of greater than or equal to 50 X 10 to the power of 9 per L on the weekly scheduled dose day from week 1 to week 12 inclusive compared to Nplate)
研究者
Dr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited