JPRN-jRCT2071220086进行中（未招募）2 期
A phase II investigator-initiated, continuation trial of 5-aminolevulinic acid hydrochloride/ sodium ferrous citrate (5-ALA-HCl/ SFC) for patients with adult-onset still's disease (AOSD) refractory to corticosteroids
适应症
试验速览
- 阶段
- 2 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
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who have completed 8 weeks of investigational drug administration in the prior study
- •2) Patients who are able to provide free and voluntary informed consent in writing and comply with the requirements of the study protocol. For subjects under 18 years of age, written consent must be obtained from a surrogate* and, in principle, from the patient him/herself.
- •*A person who has parental authority over the subject, spouse, guardian, or other equivalent person.
- •3) Female patients who can become pregnant or male patients who are sexually active with a female who can become pregnant who can obtain consent to use an effective contraceptive method (e.g., condom) during the study period and until the day after the last dose of the study drug.
排除标准
- •1) Females who are lactating, pregnant, or intend to become pregnant during the study period
- •2) Patients with serious infectious diseases (including active tuberculosis)
- •3) Patients who have been off study medication for more than 14 consecutive days between the start of the prior study and the start of the continuation study
- •4) Patients who have been off study medication for more than 7 consecutive days from the week 8 evaluation date of the prior study to the time of enrollment
- •5) Patients who received a live vaccine between the end of the prior study and enrollment
- •6) Patients with porphyria/photohypersensitivity or a history of porphyria/photohypersensitivity
- •7) Patients with hemochromatosis
- •8) Patients with known allergy or hypersensitivity to, or intolerance to, aminolevulinic acid, sodium ferrous citrate, or their additives
- •9) Patients with macrophage activation syndrome (MAS) or disseminated intravascular coagulation syndrome since the start of the prior study
- •10) Patients on dialysis
- •11) Patients with severe hepatic dysfunction (either AST or ALT > 5 times the upper limit of the institutional reference value at the week 8 evaluation date of the prior study)
- •12) Patients who have used ALA-containing or iron-based drugs or supplements, biologic agents, molecular targeted therapies, or immunosuppressive drugs listed in 5.11. Prohibited concomitant medications between the completion of the prior study and enrollment
- •13) Patients who have started a new or increased dose of methotrexate or other disease-modifying anti-rheumatic drugs between the end of the prior study and the time of enrollment
- •14) Patients with serious complications that make them unsuitable for the study as determined by the investigator or subinvestigator.
- •15) Other patients deemed inappropriate by the investigator or subinvestigator.
研究者
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