CTIS2023-505573-32-00进行中（未招募）1 期
Comprehensive Evaluation of Two Second-Line Therapeutic Approaches for Immune Thrombocytopenia (ITP) – a Pragmatic Randomized Controlled Trial - Holistic Study - RGCH006
Ostfold Hospital Trust0 个研究点目标入组 220 人开始时间: 2023年10月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female aged =18 years, Diagnosis of primary ITP of less than one-year duration and having a platelet count of < 30 x109/L measured within two weeks prior to inclusion with failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects, Failure to achieve response or relapse after at least one cycle of dexamethasone (20-40 mg daily for 4 days) or prednisone /prednisolone (1 mg/kg for at least two weeks). Shorter courses or lower doses are allowed if discontinued or modified due to side effects., Clinical need for subsequent platelet elevating therapy assessed by the physician in charge, Signed and dated written informed consent.
排除标准
- •Previous treatment for ITP with: Rituximab, other immune suppressants (including mycophenolate mofetil, azathioprine, cyclosporine), dapsone, danazol, chemotherapy (apart from vincristine as rescue therapy) or splenectomy. Short treatment with any thrombopoietic agent is allowed if given for a limited duration of a maximum of 2 weeks as rescue therapy for quick elevation of platelet count in emergency situations e.g. bleeding, Known allergy, sensitivity or contraindication to Rituximab or Avatrombopag, Patients in a severely immune compromised state, Any contraindication according to the SmPC of Rituximab (e.g. active serious infections (e.g. tuberculosis, opportunistic infections, sepsis) and serious heart failure (NYHAC IV) or serious uncontrolled heart disease) or of Avatrombopag (e.g. cirrhosis and/or severe hepatic impairment).”, Presence of active malignancy unless deemed cured by adequate treatment. Participants with the following neoplastic conditions can be included: a.Monoclonal gammopathy of undetermined significance (MGUS) or monoclonal B lymphocytosis of undetermined significance (MBUS). b.Basal/squamous cell carcinoma of the skin c.Carcinoma in situ of the cervix d.Carcinoma in situ of the breast e.Incidental histological finding of prostate cancer (TNM stage T1a or T1b)., Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or any disease that might interfere with the ability to comply with the study protocol or give informed consent, Pregnancy or lactation., Females of child-bearing potential refusing to follow effective contraceptive methods (as described in SmPC) for at least 12 months following the last administration of Rituximab or during treatment with Avatrombopag, Secondary ITP: ITP secondary to lymphoma or chronic lymphocytic leukemia; ITP secondary to the following autoimmune disorders: Systemic Lupus Erythematosus, or Antiphospholipid Syndrome; ITP secondary to Common Variable Immune Deficiency; ITP secondary the following viral infections: Human Immunodeficiency Virus or Hepatitis C Virus, Concomitant autoimmune hemolytic anemia, Active hepatitis B virus (positive HBsAg). Patients with HBsAg negative and HBV core antigen antibody positive (HBcAb) should accept to receive entecavir (Baraclude) for 12 months if they will be allocated to Rituximab. Monthly HBV DNA monitoring will be required while on treatment and for the 6 months after the last dose of the study drug, Presence of any serious comorbidity where the condition may worsen by and of the study drugs
研究者
相似试验
已完成
4 期
A clinical trial to study the effects of few anti asthmatic drug combinations on asthma patientsCTRI/2012/08/002915Dr K Ilango242
进行中（未招募）
2 期
JACCRO CC-16colorectal cancerJPRN-jRCTs061180002TSUJI Akihito90
进行中（未招募）
1 期
TRIAL TO EVALUATE CHEMOTHERAPY WITH CAPECITABINE OR CAPECITABINE PLUS MITOMYCIN C IN ADVANCED BILIARY TRACT CANCEREUCTR2011-002002-70-ITFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR57
进行中（未招募）
1 期
Clinical performance of two different resins in dental cavity restoratioRBR-9wf5v4Centro Universitário Católica de Quixadá
已完成
2 期
Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.Patients with gemcitabine-refractry advanced pancreatic cancer.JPRN-UMIN000002154Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology Pancreatic cancer study Group80