2023-507837-18-00招募中4 期
An open-label, multicenter, prospective, single-arm, exploratory study to assess role of pancreatic enzyme replacement therapy (PERT) (Creon® 25,000) in patients with Pancreatic Exocrine Insufficiency (PEI) after total gastrectomy.
BGP Products Operations GmbH19 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2025年1月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 19
- 主要终点
- Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).
研究概览
简要总结
To evaluate the effect of Creon as PERT on the nutritional status of the patient with PEI developed post-gastrectomy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female participants of any ethnic origin.
- •Participants between 18 to 80 (inclusive of both) years of age.
- •Willing to comply with the requirements of the study protocol.
- •Provide written informed consent.
- •Have previously undergone total gastrectomy.
- •Participant with pancreatic exocrine insufficiency as evidenced by clinical symptoms and confirmed by fecal elastase test.
- •Participant should not be receiving chemotherapy/radiotherapy during the last week prior to enrollment into the treatment phase.
- •Participant should not have exposure to any other investigational product within the last three months prior to enrollment into the treatment phase.
排除标准
- •On treatment with medications like somatostatin or aprotinin that directly influence pancreatic exocrine function.
- •Anticipated non-availability for study visits/procedures.
- •Vulnerable subjects (such as persons kept in detention).
- •Previously taken Creon or any other PERT product within last 1 week prior to Day 1 of pretreatment phase.
- •Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (other than CF), nutritional, endocrine, neurologic, psychiatric disease; allergy, major surgery, or any other relevant disease as revealed by history or physical examination which might limit participation in or completion of the study.
- •History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon.
- •Positive β-human chorionic gonadotropin (hCG) pregnancy test, established pregnancy, or breast-feeding at Day 1 of pretreatment phase. - Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant).
- •Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Day 1 of pretreatment phase, as judged by the investigator.
- •History of alcohol or drug abuse within the last 2 years.
- •Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
- •Lack of willingness or inability to co-operate during the conduct of the study, adequately.
结局指标
主要结局
Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).
Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).
次要结局
- Change in bodyweight from baseline
- Percentage of patients who develop symptomatic pancreatic exocrine insufficiency after gastrectomy.
- Symptoms of pancreatic exocrine insufficiency measured (as recorded in subject diaries)
- Nutritional parameters
- Gastrointestinal Quality of life index (GIQLI) questionnaire
- Treatment Emergent Adverse Events (TEAEs)
- Change in vital signs
研究者
EUClinicalTrials@viatris
Scientific
BGP Products Operations GmbH
研究点 (19)
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