EUCTR2015-005443-14-BG进行中（未招募）1 期
Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with diagnosis of definite or probable CIDP according to the EFNS/PNS Guideline 2010; including patients with Multifocal Acquired Demyelinating Sensory And Motor Neuropathy (MADSAM) or pure motor CIDP
- •2.Patients currently depending on treatment with immunoglobulins or corticosteroids
- •3.Patients with active disease, i.e. not being in remission, who are progressive or relapsing prior to trial start or during the Wash-out Phase
- •4.Weakness of at least 2 limbs
- •5.= 18 to < 80 years of age
- •6.Adjusted INCAT disability score between 2 and 9 (with a score of 2 coming exclusively from leg disability)
- •7.Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Unifocal forms of CIDP
- •2.Pure sensory CIDP
- •3.MMN with conduction block
- •4.Patients who previously failed immunoglobulin therapy
- •5.Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to baseline visit
- •6.Patients on or treated with rituximab, alemtuzumab, cyclophosphamide, or other intensive chemotherapeutic regimens, previous lymphoid irradiation or stem cell transplantation during the 12 months prior to baseline visit
- •7.Respiratory impairment requiring mechanical ventilation
- •8.Myelopathy or evidence of central nervous system demyelination or significant persisting neurological deficits from stroke, or central nervous system (CNS) trauma
- •9.Clinical evidence of peripheral neuropathy from another cause such as:
- •a.connective tissue disease or systemic lupus erythematosus (SLE)
- •b.HIV infection, hepatitis, Lyme disease
- •c.cancer (with the exception of basal cell skin cancer)
- •d.IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
- •10.Diabetic neuropathy.
- •11.Cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
- •12.Severe liver disease (ALAT 3x > normal value)
- •13.Severe kidney disease (creatinine 1.5x > normal value)
- •14.Hepatitis B, hepatitis C or HIV infection
- •15.Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or DVT
- •16.Body mass index (BMI) =40 kg/m2
- •17.Patients with uncompensated hypothyroidism (abnormally high Thyroid-Stimulating Hormone [TSH] and abnormally low Thyroxine [T4]) or known vitamin B12 deficiency if they don’t receive adequate substitution therapy
- •18.Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- •19.Known IgA deficiency with antibodies to IgA
- •20.History of severe hypersensitivity, e.g. anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of NewGam
- •21.Known blood hyperviscosity, or other hypercoagulable states
- •22.Use of other blood or plasma-derived products within three months prior to Visit 2
- •23.Patients with a past or present history of drug abuse or alcohol abuse within the preceding five years prior to baseline visit
- •24.Patients unable or unwilling to understand or comply with the study protocol
- •25.Participation in another interventional clinical study with IMP treatment currently or during the three months prior to Visit 2
- •26.Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) while on study
研究者
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