PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ALTU-135 IN PATIENT STUD

III 期、随机、双盲、安慰剂对照 ALTU-135 在患者研究中的应用

• 批准号: 7950757
• 负责人: Leslie Hendeles
• 金额: $ 2.24万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950757
• 关键词: Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Double-Blind Method; Eligibility Determination; Enzymes; Funding; Grant; Inpatients; Institution; Measures; Multicenter Studies; Pancreas; Patients; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Screening procedure; Site; Source; Time; United States National Institutes of Health; Visit; Withdrawing Treatments; cystic fibrosis patients; open label; treatment duration

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized, double-blind, placebo-controlled clinical trial which will evaluate the efficacy and safety of ALTU-135 treatment in CF patients with exocrine PI. It will be conducted as a multicenter study with participating sites having expertise in treating patients with CF. The study is divided into five phases: 1. Screening Period during which eligibility for study participation will be assessed. 2. Inpatient, off-enzyme Baseline -B Period during which each patients exocrine pancreatic function will be measured. 3. Open-Label Treatment Period during which all patients will receive ALTU-135. 4. Inpatient, Double-Blind DB Treatment Period during which half of the patients will be randomly withdrawn from treatment and receive placebo, and each patient?s exocrine pancreatic function will be measured for a second time. 5. Second Open-Label R Treatment Period during which all patients will resume treatment with open-label study drug. The total duration of treatment will not exceed 44 days and the total duration of the study excluding the Screening Visit will not exceed 64 days. Patients will be required to be inpatients for two, non-consecutive periods of approximately six to seven days.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项随机、双盲、安慰剂对照临床试验，将评估 ALTU-135 治疗患有外分泌 PI 的 CF 患者的疗效和安全性。 它将作为一项多中心研究进行，参与地点具有治疗 CF 患者的专业知识。 研究分为五个阶段： 1. 筛选期，在此期间将评估参与研究的资格。 2.住院患者，脱酶基线-B 期间，将测量每个患者的外分泌胰腺功能。 3. 开放标签治疗期，在此期间所有患者都将接受 ALTU-135。 4.住院双盲DB治疗期，在此期间，一半患者将随机退出治疗并接受安慰剂，并且将第二次测量每位患者的外分泌胰腺功能。 5. 第二个开放标签 R 治疗期，在此期间所有患者将恢复开放标签研究药物的治疗。 治疗总持续时间不会超过 44 天，不包括筛选访视的研究总持续时间不会超过 64 天。 患者将被要求住院两个非连续的时期，大约六到七天。