An Open- Label, Multicentre, Phase III Clinical Comparative Study to Evaluate the Efficacy, Safety and Pharmacokinetic Properties of Human Normal Immunoglobulin in Patients With Primary Immunodeficiency Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Primary - Incidence of acute serious bacterial infections
研究概览
简要总结
The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for follow-up assessments
详细描述
Eligible subjects will receive either test or reference as per the randomization in 1:1 ratio.
Test group: V-Immune will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose.
Reference group: Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 2 to 65 years.
- •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).
- •Treatment naive 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.
- •The screening laboratory tests must meet the following criteria:
- •WBC ≥3.5 x 109/L
- •Neutrophils ≥1.5 x 109/L
- •Platelets ≥100 x 109/L
- •Serum transaminase ≤2 times the upper limit of normal
- •Alkaline phosphatase levels ≤2 times the upper limit of normal
- •Serum creatinine ≤150 µmol/L (≤1.7mg/dl)
- •Patients must be able to adhere to the study visit schedule and other protocol requirements.
- •If subject is a female and is
- •a. -of child bearing potential, she should be practicing an acceptable method of birth control for the duration of tl1e 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
- •Patients/LAR must be capable of giving informed consent, and written consent must have been obtained prior to any study procedures.
排除标准
- •Pregnant women, nursing mothers or a planned pregnancy within 18 months of participation.
- •Patients requires any blood transfusion during the study.
- •Patients with T-cell related Severe combined immunodeficiency.
- •Patients with secondary immunodeficiency diseases
- •History or presence of any form of cancer prior to enrollment.
- •History of any autoimmune disease
- •Positive at screening for any markers of infectious blood borne viruses
- •History of adverse or allergic reactions to other IgG or blood products
- •Patients with selective IgA deficiency or antibodies IgA
- •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.
- •History of congestive heart failure [New York Heart Association class III/IV] or unstable angina
- •Recent history of migraine, hyperprolinemia, and lymphoid malignancy.
- •Requirement for use of glucocorticosteroids above 0.15 mg of prednisone equivalent/kg/day and other immunosupressive drugs as concomitant medication.
- •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.
- •Participation in any clinical study within the previous 3 months
- •Patient, who in the opinion of the Investigator, is not suitable for participation in the clinical study
研究组 & 干预措施
Test Arm
200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose.
干预措施: IVIG-VImmune (Drug)
Reference
Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose
干预措施: IVIG-Immuglo (Drug)
结局指标
主要结局
Primary - Incidence of acute serious bacterial infections
时间窗: 52 weeks
incidence of acute serious bacterial infections per patient will be assessed at 52 weeks
次要结局
- Secondary - Pharmacokinetics(52 weeks)
- Secondary Pharmacokinetics(52 weeks)
- Safety of IVIG(52 weeks)