EUCTR2013-004503-39-IT进行中（未招募）不适用
A multicenter, prospective, randomized, placebo-controlled, double-blind,parallel-group clinical trial to assess the efficacy and safety of Immune GlobulinIntravenous (Human) Flebogamma® 5% DIF in patients with Post-PolioSyndrome
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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 PPS
- •as set by the March-of-Dimes.
- •5. Subjects who are ambulatory or are able to walk with a cane
- •or other aids.
- •6. Subjects who have at least two newly weakened muscle
- •groups, and one of them in a lower extremity, as defined by
- •medical history and having a mMRC scale score of 3 or
- •greater 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
- •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 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.
- 另有 4 项未显示
研究者
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