临床试验/NCT01374490

NCT01374490已完成3 期

A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Bausch Health Americas, Inc.0 个研究点目标入组 250 人开始时间: 2011年6月7日最近更新: 2020年8月31日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bausch Health Americas, Inc.
入组人数: 250
主要终点: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female ≥ 18 years old
•History of HIV-1 infection
•On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
•Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

排除标准

•CD4 counts < 100 cells/mm3
•Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
•Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
•Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

研究组 & 干预措施

Crofelemer

Experimental

干预措施: Crofelemer (Drug)

结局指标

主要结局

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

时间窗: 48 weeks

次要结局

未报告次要终点

研究者

发起方

Bausch Health Americas, Inc.

申办方类型

Industry

责任方

Sponsor

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