Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Sustained Virologic Response at 12 weeks (SVR12)
研究概览
简要总结
The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.
详细描述
This is a multicenter, non-interventional, observational, prospective study to evaluate the efficacy, safety, and adherence to telaprevir in ex-People Who Inject Drugs (ex-PWIDs) infected with genotype 1 chronic hepatitis C and any fibrosis stage including compensated cirrhosis, who are receiving substitution therapy (eg, methadone, buprenorphine) and/or are being followed in an addiction center. Patients may be treatment naïve or relapsers. Participating physicians are to offer enrollment in this study to all eligible patients at their site in who they plan to initiate triple therapy with telaprevir, pegylated interferon alfa (PegIFN alfa), and ribavirin (RBV). A target of 115 patients will participate in this study. The duration of each patient's participation in this study will be up to approximately 60 weeks. After obtaining the signed participation agreement or ICF, selection criteria will be reviewed to verify the patient's eligibility. Data will be recorded in the electronic case report form (CRF) at 6 time points for each patient which correspond to routine care visits: inclusion, and at the patient's routine care visit closest to Week 4, 12, and 24, end of treatment, and end-of-follow-up (e.g., approximately 12 weeks after end-of-treatment). No additional blood, urine, or other biological samples will be required, and no additional investigations, beyond the routine clinical management of the patient, will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.
排除标准
- •Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.
结局指标
主要结局
Sustained Virologic Response at 12 weeks (SVR12)
时间窗: Week 12
HCV RNA \<25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
次要结局
- adherence to telaprevir until Week 12(week 12)
- adherence to PegIFN alfa and RBV(at end of treatment (week 24))
- on-treatment virologic response undetectable(week 12 and end of treatment ())
- on treatment virologic response(week 12 and end of treatment ())
- health-related quality of life based on EQ-5D(on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks))
- Hospital Anxiety and Depression Scale (HADS)(on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks))
- alcohol use disorders identification test (AUDIT)(on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks))