NCT01184846已完成3 期
A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 31
- 试验地点
- 22
- 主要终点
- Responder Rate
研究概览
简要总结
The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVIG-untreated subjects:
- •Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment.
- •Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
- •Age ≥18 years.
- •Male or female.
- •Written informed consent for study participation obtained before undergoing any study specific procedures.
- •IVIG-pretreated subjects:
- •Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score).
- •Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
- •Age ≥18 years.
- •Male or female.
- •Written informed consent for study participation obtained before undergoing any study specific procedures.
排除标准
- •A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves).
- •CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy.
- •Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke).
- •Current malignancy.
- •History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension.
- •History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident).
- •Migraine associated with IVIG infusion in the last 3 months prior to enrolment.
- •Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).
- •Subjects with serum IgA level less than 50% of the lower normal limit.
- •Known hyperprolinemia.
- •Any condition (including alcohol, drug or medication abuse) that is likely to interfere with evaluation of the study product or satisfactory conduct of the study.
- •Plasma exchange 3 months prior to enrolment.
- •Treatment with immunomodulatory agents others than steroids, methotrexate or azathioprine (e.g. interferon, TNF-α inhibitors) within 6 months before enrolment.
- •Treatment with rituximab in the 12 months before enrolment.
- •Abnormal laboratory parameters: creatinine > 1.5 times the upper normal limit (UNL), lactate dehydrogenase (LDH) > 1.5 times the UNL, C-reactive protein (CRP) > 1.5 times the UNL, hemoglobin (Hb) < 10 g/dL.
- •Ongoing HIV, hepatitis C and hepatitis B infection.
- •Participation in another clinical study (or use of another investigational medicinal product [IMP]) within 3 months prior to enrolment
- •Not able to comply with study procedures and treatment regimen.
- •Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse).
- •Pregnancy or nursing mother.
- •Intention to become pregnant during the course of the study.
- •Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
结局指标
主要结局
Responder Rate
时间窗: 25 weeks
Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score. Responders were defined as those subjects who: 1) demonstrated a "clinically meaningful improvement" between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with "clinically meaningful improvement" at the last study visit. "Clinically meaningful improvement" was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0.
次要结局
- Change in Maximum Grip Strength(Up to 34 weeks)
- Immunoglobulin G (IgG) Level(At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25))
- Severity of AEs Per Subject(34 weeks)
- Mean Change in Systolic and Diastolic Blood Pressure During Infusion(At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.)
- Severity of AEs Per Infusion(For the duration of the study, up to 34 weeks)
- Relatedness of AEs Per Infusion(For the duration of the study, up to 34 weeks)
- Relatedness of AEs Per Subject(For the duration of the study, up to 34 weeks)
- Mean Change in Pulse Rate During Infusion(At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.)
- Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.(At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation))
- Change in Adjusted INCAT Score(Up to 34 weeks)
- Change in Medical Research Council Sum Scale (MRC)(Up to 34 weeks)
- Frequency of Adverse Events (AEs)(For the duration of the study, up to 34 weeks)
- Mean Change in Body Temperature During Infusion(At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.)
研究者
研究点 (22)
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