EUCTR2019-004758-27-SE进行中（未招募）1 期
Intravenous immunoglobulin (IVIG) treatment in children with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS): an open-label trial in South-western Sweden - IVIGPANSOpen
Gillberg Neuropsychiatry Centre0 个研究点目标入组 10 人开始时间: 2020年1月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
入选标准
- •1. The subject and parents/caregivers have given written consent or assent to participate
- •in the study.
- •2. Children and adolescents between the ages of 4 and 17 years at Baseline.
- •3. Documented and confirmed pre-existing diagnosis of post-infectious PANS/PANDAS
- •4. The subject has not been treated with IVIG previously or not been treated for the last 6
- •5. If the patient is on long-term antibiotic prophylaxis, this should be unchanged one month
- •before baseline and during the trial.
- •6. Infections occurring during the trial should be treated according to standard clinical
- •7. Treatment with COX-inhibitors or corticosteroids should be discontinued at least one
- •month before baseline and during the trial. Two-three days treatment with corticosteroids
- •during and after IVIG treatment is allowed to reduce IVIG side effects such as headache
- •and nausea.
- •8. Any psychopharmacological treatment (e.g. SSRI, antipsychotics), if considered
- •essential for the subject, should be kept at a stable and unchanged dose from one month
- •before baseline and during the trial. If not considered essential, it should be discontinued
- •at least one month before baseline.
- •9. The medical records for all subjects should be available to document diagnosis, previous
- •infections and treatment.
- •10. For female participants, adequate contraception should be used, see exclusion criteria.
- •A negative pregnancy test can possibly be a requirement, specify requirement/type of
- •pregnancy test. Contraceptive requirements may also apply to male participants.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clinical evidence of any significant acute or chronic disease that, in the opinion of the
- •Investigator, may interfere with successful completion of the trial or place the subject at
- •undue medical risk. Spinal tap results are required before study start to rule out
- •encephalitis (which would need to be treated according to encephalitis treatment
- •guidelines).
- •2. The subject has had a known serious adverse reaction to immunoglobulin or any severe
- •anaphylactic reaction to blood or any blood-derived product
- •3. Females of childbearing potential who are pregnant, have a positive pregnancy test at
- •Baseline (human chorionic gonadotropin [HCG]-based assay), are breastfeeding, or
- •unwilling to practice a highly effective method of contraception (oral, injectable or
- •implanted hormonal methods of contraception, placement of an intrauterine device [IUD]
- •or intrauterine system [IUS], condom or occlusive cap with spermicidal
- •foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the
- •study Note: True abstinence: When this is in line with the preferred and usual lifestyle of
- •the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of a trial, and withdrawal
- •are not acceptable methods of contraception.)
- •4. The subject has significant proteinuria (dipstick proteinuria = 3+, known urinary protein
- •loss > 1 g/24 hours, or nephrotic syndrome), has a history of acute renal failure, has
- •severe renal impairment (blood urea nitrogen [BUN] or creatinine more than 2.5 times
- •the upper limit of normal [ULN]), and/or is on dialysis
- •5. The subject has Screening Visit values of aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) levels exceeding 2.5 times the ULN for the expected normal
- •range for the testing laboratory.
- •6. The subject has hemoglobin < 90 g/L at Screening
- •7. The subject has a known previous infection with or clinical signs and symptoms
- •consistent with current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •8. The subject has a history of or current diagnosis of deep venous thrombosis or
- •thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient
- •ischemic attack); history refers to an incident in the year prior to Baseline or 2 episodes
- •over lifetime.
- •9. The subject currently has a known hyperviscosity syndrome
- •10. The subject has an acquired medical condition that is known to cause secondary immune
- •deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic
- •or recurrent neutropenia (absolute neutrophil count less than 1.0 x 109
- •/L], or HIV
- •infection/acquired immune deficiency syndrome (AIDS).
- •11. The subject is HIV positive by NAT based on a Screening blood sample.
- •12. The subject has non-controlled arterial hypertension at a level of greater than or equal
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