CTRI/2019/09/021120已完成4 期
Prospective, Multi-centric, Single-arm, Clinical Study to Evaluate the Efficacy, Safety, and PharmacokineticProperties of ImmunoRel® in Patients with PrimaryImmunodeficiency Disease
Dr Mukesh M Desai0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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 or female, aged 2 to 65 years
- •2. Patients with confirmed diagnosis of primary immunodeficiency, predominantly antibody deficient, or common variable immunodeficiency (CVID) with a history of hypogammaglobulinemia (i.e., IgG <500 mg/dL) or X-linked agammaglobulinemia (XLA).
- •3. Treatment naïve patients eligible to receive intravenous immunoglobulin or, patients already on intravenous immunoglobulin infusions every 3 or every 4 weeks for =6 months at a dose aimed to be between 200 and 800 mg/kg with at least two documented IgG trough levels in the previous two infusions before enrolment in the study.
- •4. The screening laboratory tests must meet the following criteria:
- •a. WBC =3.5 x 109/L
- •b. Neutrophils =1.5 x 109/L
- •c. Platelets =100 x 109/L
- •d. Serum transaminase =2 times the upper limit of normal
- •e. Alkaline phosphatase levels =2 times the upper limit of normal
- •f. Serum creatinine =150 µmol/L (=1.7mg/dL)
- •5. Patients must be able to adhere to the study visit schedule and other protocol requirements.
- •6. If subject is a female and is
- •-of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as suggested by the investigator, such as a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier method), intrauterine device (IUD), or abstinence OR surgically sterile, bilateral tubal ligation done at least 6 months before the study should be documented
- •7. Patients/LAR must be capable of giving informed consent, and written consent must have been obtained prior to any study procedures.
- •8. Patients/LAR must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
排除标准
- •1. Pregnant women, nursing mothers or a planned pregnancy within 18 months of participation.
- •2. Patients with T-cell related SCID
- •3. Patients with secondary immunodeficiency diseases
- •4. History or presence of any form of cancer prior to enrolment.
- •5. History of any autoimmune disease
- •6. Positive at screening for any markers of infectious bloodborne viruses
- •7. History of adverse or allergic reactions to other IgG or blood products
- •8. Patients with selective IgA deficiency or antibodies to IgA
- •9. History of acute renal failure or severe renal impairment, or deep venous thrombosis which in the opinion of the Investigator, may place the patient at unacceptable risk for study participation and may prevent the patient from completing the study
- •10. History of congestive heart failure [New York Heart Association class III/IV] or unstable angina.
- •11. Recent history of migraine, hyperprolinemia, and lymphoid malignancy.
- •12. Requirement for use of glucocorticosteroids above 0.15 mg of prednisone equivalent/kg/day and of other immunosuppressive drugs as concomitant medication
- •13. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation and may prevent the patient from completing the study.
- •14. Participation in any clinical study within the previous 3 months
- •15. Patient, who in the opinion of the Investigator, is not suitable for participation in the clinical study.
研究者
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