EUCTR2010-021259-22-ES进行中（未招募）不适用
Seguimiento a largo plazo del DEFEND-1: Evaluación del tratamiento de respuesta permanente para la diabetes Tipo 1 de inicio precoz o reciente. Estudio de extensiónDEFEND-1 Long Term Follow Up: Durable-Response Therapy Evaluation for Early or New Onset Type 1 Diabetes Extension Study - LTF
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TolerX, Inc.
- 入组人数
- 272
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
- •Se incluirá a los sujetos solamente si cumplen todos los criterios siguientes.
- •1.Incluidos anteriormente en el DEFEND-1.
- •2.Completaron la Visita del Mes 24 del DEFEND-1; o, si se saltaron la Visita de Mes 24, han transcurrido al menos 24 meses desde la primera dosis del fármaco del estudio en el DEFEND-1.
- •3.Ausencia de problemas que, a juicio del investigador, sea probable que hagan que el sujeto sea incapaz de comprender el formulario del asentimiento o el documento de consentimiento informado (DCI) o interfieran en la capacidad del sujeto de dar su asentimiento o consentimiento informado. Tales problemas incluirían, aunque no se reducen a, psicosis o retraso mental con un CI inferior a 65.
- •4.Documento de consentimiento informado firmado por el sujeto si el sujeto es un adulto legalmente. Si el sujeto es un menor legalmente, el DCI firmado del padre/de la madre del sujeto, de ambos padres o de un tutor legal, y el formulario de asentimiento firmado por el sujeto, de acuerdo con las disposiciones legales y legislativas del país participante.
- •5.Ausencia de problemas o situaciones que, a juicio del investigador, sea probable que hagan que el sujeto sea incapaz o carezca de la voluntad para participar en los procedimientos del estudio o para completar todas las valoraciones programadas. En Alemania, las personas ingresadas en alguna institución por orden oficial o judicial no son elegibles.
- •Subjects will be enrolled only if they meet all of the following criteria.
- •1.Previously enrolled in DEFEND-1.
- •2.Completed the Month 24 visit of DEFEND 1; or, if the Month 24 visit was skipped, at least 24 months have elapsed since the first dose of study drug in DEFEND 1.
- •3.No condition that, in the investigator?s judgment, is likely to cause the subject to be unable to understand the information in the assent form or Informed Consent Document (ICD) or interfere with the subject?s ability to provide assent or informed consent. Such conditions would include, but are not limited to, psychoses or mental retardation with an IQ below 65.
- •4.Informed Consent Document signed by the subject if the subject is legally an adult. If the subject is legally a minor, ICD signed by the subject?s parent, both parents, or guardian and assent form signed by the subject, in accordance with the regulatory and legal requirements of the participating country.
- •5.No condition or situation that, in the investigator?s judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments. In Germany, persons who are confined to an institution by official or judicial order are not eligible.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Véase más arriba.
研究者
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