EUCTR2013-004503-39-HU进行中（未招募）1 期
A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in patients with Post-Polio Syndrome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- •Clinical trial subject inclusion criteria:
- •1. Male or female aged 18 to 75 years.
- •2. Subjects who understand and voluntarily signed and dated the Clinical Trial Written Informed Consent Form for his/her clinical trial participation.
- •3. Subjects with a BMI less than 30 kg/m2.
- •4. Subjects who meet the clinical criteria for diagnosis of PPSas set by the March-of-Dimes.
- •5. Subjects who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
- •6. Subjects who have at least two newly weakened muscle groups due to PPS (as defined by medical history), with at least one of them in a lower extremity, and having a mMRC scale score of 3 or greater at the MMT performed by the independent assessor at the SV.
- •7. Female subjects of child-bearing potential must have a negative test for pregnancy (human chorionic gonadotropin [HCG]-based assay).
- •8. Female subjects of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a
- •pregnancy during the course of the clinical trial.
- •9. Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples for the whole duration of the study.
- •10. Subjects who are able to walk a 2MWD of at least 50 meters at the Screening Visit (SV) and EV/IV1.
- •11. Subjects who are able to walk a consistent baseline 2MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Clinical trial subject exclusion criteria:
- •1. Subjects who have received human normal immune globulin treatment given by intravenous, subcutaneous or intramuscular route within the last 3 years.
- •2. Subjects who are not ambulatory (wheelchair-bound individuals).
- •3. Subjects with poor venous access.
- •4. Subjects with intractable pain requiring narcotics or other psychotropic drugs.
- •5. Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
- •6. Subjects with a history of intolerance to any component of the investigational products, such as sorbitol.
- •7. Subjects who are receiving corticosteroids, except for those who are taking them for asthma.
- •8. Subjects with a documented diagnosis of hyperviscosity or hypercoagulable state or thrombotic complications to polyclonal IVIG therapy in the past.
- •9. Subjects with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
- •10. Subjects who suffer from congestive heart failure, embolism, or ECG changes indicative of unstable angina or atrial fibrillation.
- •11. Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV.
- •12. Subjects with active psychiatric illness that interferes with compliance or communication with health care personnel.
- •13. Subjects with depression with scores >30 as assessed by the CESD validated scale.
- •14. Females who are pregnant or are nursing an infant child.
- •15. Subjects with any medical condition which makes clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the
- •Investigator’s judgment.
- •16. Subjects currently receiving, or have received within 3 months prior to the Screening Visit, any investigational medicinal product or device.
- •17. Subjects who are unlikely to adhere the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum/plasma sample prior to the first investigational drug infusion.
- •18. Subjects with a known selective IgA deficiency and serum antibodies anti-IgA.
- •19. Subjects with renal impairment (i.e., serum creatinine exceeds more than 1.5 time the upper limit of normal [ULN] for the expected normal range for the testing laboratory).
- •20. Subjects with AST or ALT levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory.
- •21. Subjects with hemoglobin levels <10 mg/dL, platelets levels <100,000/mm3, white blood cells count <3.0 k/µL and ESR >50 mm/h or twice above normal.
- •22. Subjects with known seropositive to HCV, HIV-1 and/or HIV-2.
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