JPRN-UMIN000012655已完成1 期
Phase I&IIa trial of KW-0761 in patients with HAM - 0761HAM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •PhaseI (1)Patients with a history of acute or chronic hepatitis or hepatic cirrhosis (2)Patients with a history of tuberculosis or with active tuberculosis (3)Patients who have developed a myocardial infarction within 12months of enrollment (4)Patients with a history of allergic reaction to antibody-based treatments (5)Patients who have taken immunosuppressant drugs or interferon-a within 6months of enrollment (6)Patients who have undergone live or attenuated/inactivated vaccinations within 4weeks of enrollment, or who plan to be vaccinated during the course of the study (7)Patients with serious complicating conditions (8)Patients with any ailment that could be exacerbated by the administration of KW-0761 (9)Patients with a history of cancer with complications. However, the following patients are not excluded: -Patients with radically resected solid tumor which have not recurred within the 5years preceding enrollment -Patients with radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma),non-invasive cervix carcinoma, and carcinoma in situ in the gastrointestinal tract or corpus of the uterus even if recurrence has occurred within 5years of enrollment (10)Patients with ALT (11)Patients who are pregnant, breastfeeding, or may become pregnant (12)Patients taking multivitamins(Alinamin,vitaminC etc.) or supplements such as fucoidan, catechin, or pentosan polysulfate within 2weeks of enrollment (13)Patients who have taken other experimental drugs within 4months of giving informed consent (14)Patients with spinal cord compression lesion complications (15)Patients with mental disabilities, epilepsy, or dementia (16)HBsAg-, anti-HBc- or HBV-DNA-positive (as measured using real-time PCR) (17)HCV antibody-positive (18)HIV antibody-positive (19)Patients considered unqualified to join the study by the investigators PhaseIIa (1)Patients who meet the exclusion criteria for PhaseI
研究者
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