CTRI/2020/06/025707尚未招募3 期
A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia
Eris Lifesciences Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and Female, aged 18 to 65 years old
- •2. Meeting the following criteria of ITP:
- •a. Thrombocytopenia by repeated lab tests.
- •b. Bone marrow examination shows megakaryocyte count increasing or at normal level with dysmaturity.
- •3. Patients with Platelet count = 20×109/L at any time during the screening period, who are non-responsive to standard or high-dose glucocorticoids.
- •4. Patients without splenectomy.
- •5. Patients willing to give written validinformed and signed consent.
排除标准
- •1. Pregnant or lactating women or patients not willing to adopt contraceptive measures during the trial.
- •2. Patient with Thrombosis history.
- •3. Patients with a diagnosis of secondary thrombocytopenia.
- •4. Patients with hepatorenal dysfunction (serum transaminase and bilirubin are over 1.5 folds of normal upper limit, and creatinine =1.5mg/dl).
- •5. Patients with severe cardiorespiratory dysfunction.
- •6. Patients who have active malignancy.
- •7. Patient with hypersensitivity to study drug or any of its excipients.
- •8. Patients on other thrombopoietin receptor agonists (Eltrombopag) as they compete with TPIAO for TPO receptor binding.
- •9. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •10.Patients with suspected inability to comply with the study procedure.
研究者
相似试验
进行中（未招募）
3 期
A study to evaluate Immunogenicity and Safety of a Booster Dose of Sputnik Light Vector Vaccine for prevention of COVID-19 Indian Subjects.CTRI/2022/04/041792Dr Reddys Laboratories Limited
招募中
1 期
A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumabSmall-Cell Lung Cancer (SCLC)MedDRA version: 21.1Level: PTClassification code: 10041068Term: Small cell lung cancer extensive stage Class: 100000004864CTIS2023-503868-16-00F. Hoffmann-La Roche AG658
进行中（未招募）
3 期
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)Early Breast CancerJPRN-jRCT2031210363Tanja Badovinac Crnjevic4,100
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Giredestrant Plus Everolimus Compared with the Physician’s Choice of Endocrine Therapy Plus Everolimus in Patients with Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast CancerEstrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor and endocrine therapyMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864MedDRA version: 23.0Level: LLTClassification code: 10070575Term: Estrogen receptor positive breast cancer Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10072740Term: Locally advanced breast cancer Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10027475Term: Metastatic breast cancer Class: 10029104CTIS2023-506821-12-00Genentech Inc.367
进行中（未招募）
1 期
Study of Durvalumab with Tremelimumab Versus standard of care chemotherapy in lung cancer (NEPTUNE Study).Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology.MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864EUCTR2015-002197-21-BGAstraZeneca AB1,330