EUCTR2016-002181-32-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Patients with Alport Syndrome - A Phase 2 Study to Evaluate Weekly RG012 Injections in Alport Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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.Capable of providing written informed consent
- •2. Male or female subjects aged 18 to 65 years (inclusive)
- •Capable of providing written informed consent
- •3. Confirmed diagnosis of Alport syndrome (clinical, histopathologic, and/or genetic diagnosis)
- •4. As estimated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or creatinine–cystatin C equation, all 3 of the following eGFR criteria must be met:
- •eGFR at the initial screening measurement between 45 and 90 ml/min/1.73 m2
- •Declining eGFR at a rate =5ml/min/1.73m2 per year
- •Final screening/baseline eGFR >30ml/min/1.73m2
- •5.Proteinuria =500 mg protein/g creatinine at initial screening and baseline visits
- •6. On a stable dosing regimen of an ACE inhibitor and/or ARB for =30 days prior to screening
- •7. Female subjects of childbearing potential must agree to use an acceptable methods of contraception from screening through 30 days after the last dose of study drug
- •8. Male subjects with female partners of childbearing potential must agree to use one an acceptable contraception methods from the time of the first dose of study drug through 30 days after the last dose of study drug
- •9. Negative drug screen for opiates, cocaine, heroin, phencyclidine, amphetamines (including ecstasy), barbiturates, and benzodiazepines
- •10. Negative screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
- •11. Screening hematology, clinical chemistries, coagulation, and urinalysis are not clinically significant as assessed by the Investigator, and the following criteria are met:
- •Platelets >100x109/L
- •Total white blood cells >3.0x109/L and absolute neutrophil count >1.5x109/L
- •Hemoglobin >10 g/dL for females and >11 g/dL for males
- •Total and direct bilirubin <1.5x upper limit of normal (ULN), unless elevated bilirubin is associated with a known benign condition (e.g., Gilbert's syndrome)
- •Alanine aminotransferase (ALT) <3x ULN
- •Aspartate aminotransferase (AST) <3x ULN
- •Alkaline phosphatase (ALP) <3x ULN
- •12. Agree not to start any new prescription medication and to maintain stable regimens of existing medications, except as prescribed or approved by the Investigator, or if required in an emergency
- •13. Agree not to take any over-the-counter medication or herbal supplements during the study, except as instructed or approved by the Investigator
- •14. Able to understand all study procedures in the informed consent form (ICF) and willing to comply with all aspects of the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Causes of chronic kidney disease aside from Alport syndrome (including, but not limited to, diabetic nephropathy, hypertensive
- •nephropathy, lupus, IgA nephropathy)
- •2. ESRD as evidenced by ongoing dialysis therapy or history of renal transplantation
- •3. Female subjects who are pregnant or lactating
- •4. Concurrent clinically significant medical diagnosis (other than Alport
- •syndrome) that would potentially interfere with the subject's study compliance or confound the study results, including but not limited to: significant or unstable cardiac disease (unstable angina, myocardial infarction within the last 6 months, coronary heart disease, congestive heart failure, prolonged QT syndrome [torsade de pointes], significant arrhythmia, and/or any other clinically significant ECG abnormalities); cancer; uncontrolled seizure disorder; chronic infection (e.g., tuberculosis); diabetes; and/or significant thyroid disease
- •5. Any history of malignancy within the last 1 year (history of localized basal cell or squamous cell carcinoma that has been excised/appropriately treated is not considered exclusionary)
- •6. Concurrent social conditions (e.g., drug or alcohol abuse) that would potentially interfere with the subject's study compliance
- •7. Use of over-the-counter medications or herbal supplements that may interact with the bioavailability of the investigational product or use of alternative medicines that may have influence on the disease outcome.
- •8. Mental disability or history of or current significant psychiatric disease that may impair ability to provide informed consent or impact compliance with study procedures
- •9. Clinically significant illness within 30 days prior to screening that in the judgment of the Investigator could interfere with interpretation of study results, impair compliance with study procedures, or impact the safety of the subject
- •10. Participation in a recent investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days or 5 half lives, whichever is longer, prior to screening
- •11. History or presence of hypersensitivity, idiosyncratic reaction, or allergic reaction to the study drug, inactive ingredients, or related compounds
- •12. History of any clinically significant reaction (in the judgment of the Investigator) to previous injection of an oligonucleotide product
- •13. History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- •14. Any other condition or circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety and well-being
研究者
相似试验
进行中（未招募）
1 期
Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077739Term: Pulmonary arterial hypertension WHO functional class ISystem Organ Class: 100000004855EUCTR2019-002669-37-ATGB002, Inc.80
进行中（未招募）
1 期
A Phase 2 Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection FractioHeart failure (HF) with reduced ejection fraction (HFrEF)MedDRA version: 26.1Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541CTIS2023-508736-62-00Cardurion Pharmaceuticals Inc.400
进行中（未招募）
1 期
This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid TreatmentSubjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid TreatmentMedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2021-000648-23-DEAbbVie Deutschland GmbH & Co. KG160
招募中
1 期
Efficacy and Safety of Rosnilimab in Subjects with Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947CTIS2023-508679-34-00Anaptysbio Inc.147
进行中（未招募）
1 期
This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid TreatmentSubjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid TreatmentMedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2021-000648-23-ITABBVIE DEUTSCHLAND GMBH & CO. KG200