CTRI/2009/091/000860已完成3 期
A multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols 10%) in patients with idiopathic (immune) thrombocytopenic purpura. - Nil
Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 75 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
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.To be male or female.
- •2.To be 18 to 70 years of age.
- •3.To have a diagnosis of chronic ITP.
- •4.To have a platelet count ≤ 20 x 10.e9/L.
- •5.To sign an informed consent form.
排除标准
- •1.Has a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia.
- •2.Has a diagnosis of secondary immune thrombocytopenia.
- •3.Has a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product.
- •4.Is suffering a serious and/or life-threatening hemorrhage/bleeding defined as:
- •-Any intracranial or central nervous system bleeding.
- •-Any hemorrhagic event in which the subject is at risk of death at the time of the event.
- •5.Is known to have IgA deficiency.
- •6.Has a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
- •7.Is anemic (Hgb 9 g/dL).
- •8.Is known to have a positive test for either HIV 1/2 or HCV
- •9.Has a splenectomy within the prior 8 weeks to the screening visit.
研究者
相似试验
已完成
不适用
A clinical trial to test the safety and effectiveness of Neuralzhein in management of memory loss related to age.CTRI/2019/08/020711exxus Laboratories DBA OPUS PHARMA
已完成
2 期
Clinical study on JPF-16 Capsules in Sexual Dysfunction in FemalesCTRI/2017/06/008791Chatarubhuj Pharmaceutical Co30
招募中
1 期
A clinical study to assess how safe and effective it is for subjects with hepatocellular carcinoma (HCC) to receive radiation therapy with TheraSphere followed by immunotherapy (durvalumab and tremelimumab treatment)Hepatocellular CarcinomaMedDRA version: 21.1Level: LLTClassification code: 10049010Term: Carcinoma hepatocellular Class: 10029104CTIS2023-508945-41-00Biocompatibles UK Limited107
已完成
3 期
To evaluate safety and performance of CREDENCEâ?¢ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemiafollowing Percutaneous Transluminal Angioplasty of below the knee arteries.CTRI/2016/11/007473Meril Life Sciences Pvt Ltd30
已完成
2 期
Clinical study on Ayuvita Forte Capsule in irregular periods with cysts in ovary.CTRI/2019/11/022183Welex Laboratories Pvt Ltd25