NCT03395704已完成2 期
A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis
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
- 70
- 试验地点
- 2
- 主要终点
- Effect of LJPC-401 Versus Placebo on Blood Iron Levels
研究概览
简要总结
This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients with clinical diagnosis of hereditary hemochromatosis
- •Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis
- •Patients with serum ferritin and TSAT levels above treatment guidelines
- •Female patients of child bearing potential must have a negative pregnancy test and must be using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug
- •Males must be surgically sterile (vasectomy), or using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug
- •Patient must be willing and able to provide written informed consent
排除标准
- •Patients receiving iron chelation therapy within 7 days prior to the first dose of study drug
- •Patients initiating phlebotomy treatments less than 3 months prior to the first dose of study drug
- •Pregnant or lactating women
- •Patients taking an immunosuppressive agent without prior Sponsor approval
- •Patients participating in an unapproved investigational drug or investigational therapeutic device within 30 days of study drug
- •Patients who are unwilling or unable to comply with the study protocol requirements
- •Patients with type 1 or poorly controlled type 2 diabetes
- •Patients with a concomitant disease, disability or condition, including laboratory abnormality and ECG findings, which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, clinically significant arrhythmias, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease
研究组 & 干预措施
LJPC-401
Active Comparator
LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial
干预措施: LJPC-401 (Drug)
Placebo
Placebo Comparator
0.9% Sodium Chloride Injection, USP, or equivalent
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of LJPC-401 Versus Placebo on Blood Iron Levels
时间窗: 16 Weeks
Percentage change in transferrin saturation (TSAT) as measured by blood laboratory tests.
次要结局
- Effect of LJPC-401 Versus Placebo on the Total Number of Treatment-emergent Adverse Events(20 Weeks)
- Effect of LJPC-401 Versus Placebo on Blood Iron Levels(16 Weeks)
- Effect of LJPC-401 Versus Placebo on Number of Phlebotomies(16 Weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction PatientsMyocardial InfarctionNCT00078013Tanabe Pharma Corporation414
已完成
2 期
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)NCT03938246Sagimet Biosciences Inc.142
终止
2 期
Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin GraftsThird Degree BurnsDiabetesNCT01715012Noveome Biotherapeutics, formerly Stemnion1
已完成
2 期
A Study of CM310 in Subjects With Moderate to Severe AsthmaAsthmaNCT05186909Keymed Biosciences Co.Ltd52
已完成
2 期
Phase II Study of Hemay005 in Patients With Active Ankylosing SpondylitisActive Ankylosing SpondylitisNCT05407246Tianjin Hemay Pharmaceutical Co., Ltd90