CTRI/2021/08/035609尚未招募4 期
A prospective, single-arm, multicentre study to assess safety and efficacy of Romy�® (Romiplostim Powder for Injection) (Intas Pharmaceuticals Ltd., India) in patients with chronic refractory immune (idiopathic) thrombocytopenic purpura (ITP)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
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.Patients with confirmed chronic immune thrombocytopenia (lasting more than 6 months since diagnosis) as diagnosed by the investigator who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- •Note:- Patients with ongoing ITP medications (corticosteroids, immunoglobulin, danazol, and azathioprine) at a constant dose and schedule at the time of screening will be eligible.
- •2.Patients aged more than or equal to 1 year
- •3.Value of platelet counts taken during screening must be,
- •Ã¢â?¬Â¢Less than 30 in to 10 raised to 9 per L for those patients not receiving ITP therapy.
- •Ã¢â?¬Â¢Less than 50 in to 10 raised to 9 per L for those patients receiving stable dose of ongoing ITP medication.
- •4.Patients in good health as determined by past medical history, physical examination, vital signs (heart rate, blood pressure, respiratory rate and body temperature), ECG and laboratory tests at screening.
- •5.Written informed consent/assent from participants or legally acceptable representative (as applicable) must be obtained before any assessment is performed.
- •6.Adequate hematologic, renal, and liver function during screening:
- •Ã¢â?¬Â¢Hemoglobin greater than 10.0 g/dL
- •Ã¢â?¬Â¢Serum creatinine less than or equal to 1.5 in to the upper limit of normal (ULN)
- •Ã¢â?¬Â¢Total serum bilirubin less than or equal to 1.5 in to the ULN
- •Ã¢â?¬Â¢Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 in to the UL
- •7.Subjects legally acceptable representative or subject (if applicable) is able to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •1.Patients who does not have increased risk of bleeding though having thrombocytopenia
- •2.Patients having thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP.
- •3.History of immunodeficiency diseases, including a positive HIV test result.
- •4.Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •5.Patients with any clinical condition (other than chronic immune thrombocytopenia) or drug intake that increases the risk for bleeding.
- •6.History of hypersensitivity to the study drug or any recombinant Escherichia coli derived product.
- •7.Less than 8 weeks since major surgery (including laparoscopic splenectomy)
- •8.Any condition that in the opinion of investigator could affect the safety of patient participating in the study.
- •9.Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •10.Pregnant or lactating mother.
- •11.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using acceptable methods of contraception during the study and for at least 3 months following last study drug administration.
- •1.Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile or six months of amenorrhea with serum FSH level more than 40 mIU/ml; or have had surgical bilateral oophorectomy at least 6 months ago.
- •12.Fertile males, defined as all males physiologically capable of conceiving offspring, unless the subjects agree to comply with effective contraceptive methods for the entire duration and refrain from fathering a child during the study and for at least 3 months following last study drug administration.
- •13.Significant illness within two weeks prior to initial dosing.
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