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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项随机、双盲、安慰剂对照的临床试验，将评估Altu-135治疗外分泌性PI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。 这项研究分为五个阶段： 1.筛选期间将评估参加研究的资格。 2.住院患者非酶基线-B期，在此期间将测量每个患者的胰腺外分泌功能。 3.所有患者将接受ALTU-135的开放标签治疗期。 4.住院双盲DB治疗期间，随机抽出一半患者接受安慰剂治疗，并对每例患者进行第二次胰腺外分泌功能测定--S。 5.第二个开放标签R治疗期，在此期间，所有患者将恢复使用开放标签研究药物治疗。 总疗程不超过44天，不包括筛查访视的总研究期限不超过天。患者将被要求住院两个不连续的时期，大约六到七天。

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 Inpatient, Double-Blind DB Treatment Period during which half of the patients will be randomly withdrawn from treatment and receive placebo, and each patient?s exocrine pancreatic function will be measured for a second time. 5.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.