EUCTR2008-005830-63-LV进行中（未招募）不适用
A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects with Moderate to Severe Psoriasis
Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 55 人开始时间: 2009年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent / (Assent, if applicable) and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). Guardian or proxy consenter informed consent has been obtained for pediatric studies.
- •2. Subject is male or female, between and inclusive of 12-17 years of age at baseline.
- •3. Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area (where the subject’s hand [palm plus digits] represents approximately 1% of the body surface area).
- •4. Subject is a candidate for systemic treatment or phototherapy.
- •5. Subject is in good health (as determined by the investigator) and alefacept is not
- •contraindicated.
- •6. Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening.
- •7. Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study.
- •8. Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT and AST.
- •9. Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose.
- •10. Subject meets medication washout requirements and agrees to follow medication restrictions during the study (see Appendix 1).
- •11. Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis (e.g., erythrodermic, guttate, pustular or palmar/plantar pustulosis).
- •2. Subject has a known hypersensitivity to alefacept or any excipient of the study medication.
- •3. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 12 weeks prior to the first dose of study drug.
- •4. Subject has a fever (body temperature = 38°C (or >37 ºC for sites in Latvia)) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug.
- •5. Subject is known to be positive for HIV antibodies.
- •6. Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening.
- •7. Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening.
- •8. Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug.
- •9. Subject is currently enrolled in any other study and/or previous participation in this study.
- •10. Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks.
- •11. Subject has a history of malignancy (other than non-melanoma skin cancers).
- •12. Subject has a chronic condition (e.g., diabetes or hypertension) which is not well controlled.
- •13. Subject is pregnant or nursing.
- •14. Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety.
- •15. Subject has a history of severe allergic or anaphylactic reactions.
研究者
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