跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT02265952
NCT02265952已完成2 期

An Open-Label, Single-Arm, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Single and Multiple Doses of REGN1500 in Patients With Homozygous Familial Hypercholesterolemia

Regeneron Pharmaceuticals0 个研究点目标入组 9 人开始时间: 2015年2月4日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
9
主要终点
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Men and women ≥18 years of age at the time of the screening visit
  • •Diagnosis of homozygous familial hypercholesterolemia (HoFH)
  • •Willing to consistently maintain usual diet for the duration of the study

排除标准

  • •Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit
  • •Having undergone lipid apheresis within 4 weeks prior to the screening visit
  • •Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit
  • •Previous participation in any clinical trial of REGN1500
  • •Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

研究组 & 干预措施

Open-label

Experimental

Open-label REGN1500

干预措施: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC (Drug)

结局指标

主要结局

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period

时间窗: Baseline (Week 0) up to Week 4

Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

次要结局

  • Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period(Baseline (Week 0) up to Week 4)
  • Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period(Week 2 to Week 4)
  • Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period(Week 2 to Week 4)
  • Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period(Baseline (Week 26) to Week 214)
  • Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period(Baseline (Week 0) to Week 26)
  • Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) up to Week 26)
  • Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period(Baseline (Week 26) up to Week 214)
  • Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) up to Week 16)
  • Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period(Baseline (Week 0) to Week 16)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验

招募中
2 期
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative ResectionCarcinoma, Hepatocellular
NCT06454578Qilu Hospital of Shandong University30
招募中
1 期
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic CancerPancreatic Cancer
NCT06758544Guangdong Provincial People's Hospital18
终止
4 期
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPHPrimary Pulmonary Arterial HypertensionChronic Thromboembolic Pulmonary Hypertension
NCT04954742Heidelberg University30
Unknown
2 期
A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid CancerRefractory Cancer
NCT03199677Chinese Academy of Medical Sciences40
进行中（未招募）
2 期
Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard TherapyColorectal Cancer
NCT05435313Fudan University39