A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,310
- 试验地点
- 47
- 主要终点
- Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
研究概览
简要总结
This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to PERT.
详细描述
This is a multicenter, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed CF patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. Data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection.
This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research & Development, LLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Patients (PERT-exposed and unexposed controls) must meet the following criteria:
- •Have a blood draw planned as part of their standard of care following enrollment into the study; and
- •Provide informed consent/assent.
- •Patients in the PERT-Exposed Group must meet the following criteria:
- •Have been diagnosed with CF; and
- •Have received PERT for a minimum of 6 months.
- •Patients in the Unexposed Control Group must meet the following criteria:
- •Be under medical management for chronic disease;
- •Never received any PERT product; and
- •Match an enrolled PERT-exposed patient based on age and region-of-residence.
- •Have a blood draw planned to be performed within 180 days of the matched PERT-exposed patient blood draw.
排除标准
- •Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine derived insulin. This exclusion does not apply to previous porcine-derived heparin exposure. ;
- •Refuses blood collection; or
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
时间窗: 18 Months
Seroprevalence of antibodies to selected porcine viruses in cystic fibrosis (CF) patients exposed to porcine-derived pancreatic enzyme replacement therapy (PERT) compared with a 1:1 matched control group of patients with chronic disease unexposed to PERT
次要结局
未报告次要终点