EUCTR2017-003598-33-GB进行中（未招募）1 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
a Jolla Pharmaceutical Company0 个研究点目标入组 76 人开始时间: 2017年12月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
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. Patients with a clinical diagnosis of hereditary hemochromatosis.
- •2. Patients who are prescribed therapeutic phlebotomy for the treatment of hereditary hemochromatosis.
- •3. Patients = 18 years of age.
- •4. Patients with a serum ferritin level from >100 ng/mL.
- •5. Patients with a TSAT level > 45%.
- •6. Female patients must be of non-childbearing potential, or using a highly effective method of contraception during participation in the study and for 30 days after the last dose of study drug. Highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate when used consistently and correctly. Refer to Protocol Section 10.1.6.4.1
- •for the list of highly effective methods of contraception that can be used in this study.
- •7. Female patients of child bearing potential must have a negative serum pregnancy test at Screening (within 30 days prior to the first dose of study drug) and negative urine pregnancy test at Day 1 (ie, prior to initial dosing of study drug).
- •8. Male patients 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. Highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate when used consistently and correctly. Refer to Protocol Section 10.1.6.4.1 for the list of highly effective methods of contraception that can be used in this study.
- •9. Patient must be willing and able to provide written informed consent.
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients receiving iron chelation therapy within 7 days prior to the
- •first dose of study drug.
- •2. Patients recently diagnosed, who have initiated phlebotomy treatments less than 3 months prior to the first dose of study drug.
- •3. 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. Patients with depression are eligible if receiving a
- •stable dose of medication for at least 90 days prior to the first dose of
- •study drug.
- •4. Pregnant or lactating women.
- •5. Patients taking an immunosuppressive agent that has not been
- •approved for use by La Jolla (excluding topical over-the-counter steroids, and nonsteroidal anti-inflammatory drugs). Refer to Section 7.1 for the list of prohibited medications and procedures.
- •6. Patients participating in an unapproved investigational drug or investigational therapeutic device study within 30 days prior to study drug dosing, ie, there must be at least 30 days in between the last dose on a prior study and the first dose administration on this trial.
- •7. Patients who are unwilling or unable to comply with the study protocol requirements.
- •8. Patients with type 1 diabetes or type 2 diabetes with haemoglobin Alc greater than 8% within 2 months prior to randomisation.
- •9. Patients with uncontrolled active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- •10. Patients with Child Pugh class C cirrhosis or liver failure.
- •11. Patients with severe congestive heart failure (NYHA = Class 4).
- •12. Patients who have advanced renal failure with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2.
- •13. Patients with a history of allergic reaction to hepcidin or excipients.
- •14. Patients who have planned surgery (excluding dental surgery or simple dermatologic procedures) during participation in this study.
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