New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 1
- 主要终点
- Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
研究概览
简要总结
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification
详细描述
The cross sectional survey data will be collected on a pre-defined questionnaire from Gastroenterologist and Hepatologist. The questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic HCV and adverse event details.
The questions related to Pharmacovigilance and safety assessment includes the International Nonproprietary Names (INN) unless it is prescribed brand of Getz Pharma. All adverse events associated with the prescribed treatment will be recorded. Data on outcome assessment will be based on action taken due to AE and other reported details. Seriousness of adverse event will also be recorded as per the ICH classification and severity of medical event will be assessed as per Karch and Lasagna classification.
All the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients.
Patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. However, patient data secrecy will follow ICH GCP requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Written informed consent
- •Male or Female patient
- •Age of patient ≥18 years
- •Patients already diagnosed with HCV and on DAAs therapy.
排除标准
- •Written informed consent
- •Male or Female patient
- •Age of patient ≥18 years
- •Patients already diagnosed with HCV and on DAAs therapy.
结局指标
主要结局
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
时间窗: 12 months
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
次要结局
- Percentage of patients reported severity of medical event as per Karch and Lasagna classification(12 months)