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临床试验/NCT02803138
NCT02803138已完成不适用

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C - An Observational Study in Israel (CITRINE STUDY)

AbbVie18 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2016年7月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
256
试验地点
18
主要终点
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

研究概览

简要总结

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.

详细描述

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Participants with HCV genotype 1 or 4

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks

干预措施: Ombitasvir/paritaprevir/ritonavir (Drug)

Participants with HCV genotype 1 or 4

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks

干预措施: Dasabuvir (Drug)

Participants with HCV genotype 1 or 4

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks

干预措施: Ribavirin (Drug)

Participants with HCV genotype 1 or 4

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks

干预措施: Patient support program (Behavioral)

结局指标

主要结局

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

时间窗: 12 weeks after the last actual dose of study drug

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug.

次要结局

  • Percentage of Participants With Virologic Response at End of Treatment (EoT)(Up to 24 weeks)
  • Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment(12 weeks (at least 70 days) after the last actual dose of study drug)
  • Percentage of Participants With Relapse(Up to 48 weeks after the last actual dose of study drug)
  • Percentage of Participants With Viral Breakthrough(Up to 24 weeks)
  • Percentage of Participants With On-treatment Virologic Failure(12 weeks after the last actual dose of study drug)
  • Percentage of Participants Meeting Relapse Criteria(12 weeks after the last actual dose of study drug)
  • Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria(12 weeks after the last actual dose of study drug)
  • Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria(12 weeks after the last actual dose of study drug)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (18)

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