NCT01900886Unknown不适用
Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "
Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria11 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 263
- 试验地点
- 11
- 主要终点
- Sustained Viral Response (SVR)
研究概览
简要总结
Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.
详细描述
Secondary objectives:
- Describe the management of patients with personality disorders on treatment for hepatitis C in the prison.
- Describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age.
- •Patients with expected prison stay beyond the duration of follow-up period of the study.
- •Patients with chronic HCV infection and detectable viral load to initiate treatment with standard therapy.
- •Patients their written informed consent to participate in the study.
排除标准
- •Patients previously treated with Interferon (IFN) and Ribavirin (RBV).
- •Patients can not read or understand a written questionnaire at the discretion of the investigator.
研究组 & 干预措施
Pegasys, injection subcutaneous
Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)
干预措施: Peginterferon alfa-2a (Other)
Pegasys, injection subcutaneous
Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Viral Response (SVR)
时间窗: RNA-VHC at weeks 24 or 48
次要结局
未报告次要终点
研究者
研究点 (11)
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