CTIS2023-509077-23-00招募中1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex on subjects with Ataxia Telangiectasia. - IEDAT-04-2022
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Subject meets clinical criteria for diagnosis of A-T. The neurological signs of A-T (incoordination of the head and eyes in lateral gaze deflection, gait ataxia associated with an inappropriately narrow base) must be documented. Such signs of A-T illustrate the body systems in which changes shall be confirmed, but the listed signs are examples and other changes in those systems may be observed and documented to confirm the diagnosis of A-T., Subject is in autonomous gait or is helped by periodic use of a support (i.e., ICARS score for Item 1 – Walking Capacities between 0 and 4 included)., Subject is at least 6 years of age (Day 0/Dose 1 must be on or after date of 6th birthday), of either sex., Genetic confirmation of A-T., Body weight =15 kg., The subject and parent/caregiver (if below the age of consent), or a legal representative, has provided written informed consent to participate. If consent is provided solely by the caregiver in accordance with local regulations, the subject must provide assent to participate in the study, to the extent possible.
排除标准
- •General - A disability that may prevent the subject from completing all study requirements., Medical History and Current Status - Any clinically significant abnormality on standard laboratory examinations (hematology, biochemistry, urinalysis) at screening that remains abnormal on repeat testing, if considered as a possible sign of a clinical condition putting the subject at risk if enrolled. Eligibility of subjects with abnormal laboratory test values will be determined by the Investigator in consultation with the Medical Monitor., Medical History and Current Status - Subject with an early morning plasma cortisol level below 3-5 µg/dL (depending on assay) or subject exhibits signs or symptoms of adrenal insufficiency with an early morning plasma cortisol level below 10 µg/dL, and fails the ACTH stimulation test at screening., Medical History and Current Status - Confirmed hemoglobinopathies, e.g., hemoglobin C disease, sickle cell anemia, hereditary spherocytosis, or thalassemia., Medical History and Current Status - Current chronic or acute significant renal and/or hepatic impairment that in Investigator’s opinion will impact subject participation in the study., Medical History and Current Status - Subjects with suicidal ideation, Medical History and Current Status - Females that are pregnant or breast feeding. Females of childbearing potential using an adequate birth control method, as determined by their Health Care Provider, will be eligible. For further details on the highly effective contraceptive measures, Prior/Concomitant Medication - Any previous oral or parenteral steroid use within 6 weeks before Baseline. Treatment with inhaled or intranasal steroids for asthma or allergies, as well as use of topical steroids will be permitted., Prior/Concomitant Medication - Chronic condition or prior allergic reaction representing a contraindication to the use of dexamethasone or other steroid drugs., Prior/Concomitant Medication - Has participated in any other trial with an investigational drug and received a dose within 30 days or at least 5 half-lives (whichever is greater) prior to the Screening visit., Prior/Concomitant Medication - Has participated in a previous trial with EryDex treatment, General - Current participation in another clinical study. Participation in observational, non-interventional studies is allowed with approval by the Medical Monitor as long as study investigational endpoint raters can remain blinded to the assessments from other studies, and as long as the other study participation does not interfere with participation in this study., Prior/Concomitant Medication - Requires any concomitant medication prohibited by the protocol, Medical History and Current Status - Immune impairment that includes CD4+ lymphocytes count <400/mm3 (for subjects less than 7 years old) or <150/mm3 (for subjects =7 years old). In presence of oral infections, like oral candidiasis, documented at screening or recurrent as per medical history documentation, the limit increases to <200/mm3 (for subjects =7 years old)., Medical History and Current Status - History of severe impairment of the immunological system such that steroid treatment would be contraindicated., Medical History and Current Status - Loss/removal of 250 mL or more of blood within the past 4 weeks prior to screening., Medical History and Current Status - Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years., Medical History and C
研究者
相似试验
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail - AMG 785 20062017Acceleration of fracture healingMedDRA version: 12.1Level: LLTClassification code 10043827Term: Tibia fractureEUCTR2008-008392-34-ITAmgen Inc.400
进行中（未招募）
1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT) - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT)Acceleration of fracture healingMedDRA version: 13.1 Level: PT Classification code 10043827 Term: Tibia fracture System Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2008-008392-34-GBAmgen Inc400
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (erlotinib) Following Complete Tumor Resection and with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-positive Tumors.Estudio fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de una monoterapia con Tarceva® (erlotinib) tras una resección tumoral completa, con o sin quimioterapia adyuvante, en pacientes con cáncer de pulmón de células no pequeñas en estadios IB-IIIA que tienen tumores EGFR-positivo. - RADIANTEUCTR2005-001747-29-ESOSI Pharmaceuticals, Inc.945
进行中（未招募）
1 期
/aEUCTR2015-005241-31-NOEryDel S.p.A.175
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine theEfficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary NailEUCTR2009-015939-33-SEAmgen Inc330