EUCTR2013-001870-38-SE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alphal-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alphal-Antitrypsin Deficiency - SPARTA
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
- 339
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
- •1. Have a documented total alpha1-PI serum level < 11 µM.
- •2. Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or at-risk” alleles. If the genotype has yet to be documented, genotyping (i.e., allelic discrimination) and phenotyping will be performed at the Screening (Week -3) Visit.
- •3. At the Screening (Week -3) Visit, have a post-bronchodilator FEV1 = 30% and < 80% of
- •predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic
- •Obstructive Lung Disease [GOLD] stage II or III).
- •4. Have a carbon monoxide diffusing capacity (DLCO) = 60% of predicted (corrected for HgB) within the past 2 years OR evidence of pulmonary emphysema on CT scan within the past 2 years per the Investigator’s judgment.
- •5. Have clinical evidence of pulmonary emphysema per the Investigator’s judgment.
- •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 305
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1. Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening (Week -3) Visit.
- •2. Has received alpha1-PI augmentation therapy within one month of the Screening (Week -3) Visit.
- •3. Has had a COPD exacerbation within the 5 weeks prior to the Screening (Week -3) Visit or during the Screening Phase. Investigator discretion should be used to determine if a subject is appropriate for study participation if the subject has had a COPD exacerbation which occurred more than 5 weeks prior to the Screening (Week -3) Visit.
- •4. Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan.
- •5. History of lung or liver transplant.
- •6. Any lung surgery during the past 2 years (excluding lung biopsy).
- •7. On the waiting list for lung surgery, including lung transplant.
- •8. Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking.
- •9. History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
- •10. Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e.,
- •10 mg every 2 days) within the 5 weeks prior to the Screening (Week -3) Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase. It is recommended to maintain the same dose throughout the study.
- •11. Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening (Week -3) Visit or during the Screening Phase.
- •12. Known selective or severe Immunoglobulin A (IgA) deficiency.
研究者
相似试验
进行中（未招募）
1 期
An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Heterozygous Familial HypercholesterolemiaHypercholesterolaemiaMedDRA version: 20.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-001903-60-DKSanofi-aventis recherche & développement500
进行中（未招募）
1 期
An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Heterozygous Familial HypercholesterolemiaHypercholesterolaemiaMedDRA version: 20.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-001903-60-HUSanofi-aventis recherche & développement500
进行中（未招募）
1 期
Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia (CAH)MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850EUCTR2020-004381-19-ESeurocrine Biosciences, Inc.81
进行中（未招募）
1 期
This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)Moderate to Severe Rheumatoid ArthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2020-005303-39-GRAbbVie Deutschland GmbH & Co. KG425
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 16.1Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-SKRegeneron Pharmaceuticals, Inc.803