Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 43
- 主要终点
- Treatment Duration Compliance Rate
研究概览
简要总结
The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.
详细描述
The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic Hepatitis C (HCV) genotype 1
- •Detectable HCV-RNA within 180 days of screening
- •Age ≥ 18 years
- •Weight > 40 kg
- •Patient and partner(s) must agree to use acceptable methods of contraception
- •Written informed consent
排除标准
- •Known co-infection with HIV or HBV
- •Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
- •Currently taking or planning on taking any prohibited medications
- •Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •Diabetes and/or hypertension with clinically significant ocular examination findings
- •Pre-existing psychiatric condition(s)
- •History of severe and uncontrolled psychiatric disorders
- •Active alcohol or drug abuse (not including marijuana)
- •Pre-existing medical condition that could interfere with the patient's participation in the study
- •Chronic obstructive pulmonary disease
- •Abnormal lab values
研究组 & 干预措施
Group A - HCEE
Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.
干预措施: Patient education and management skills training (Other)
Group B - Community Sites
Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.
干预措施: Educational Intervention (Procedure)
结局指标
主要结局
Treatment Duration Compliance Rate
时间窗: End of treatment up to treatment week 48
The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).
次要结局
- Drug Exposure(End of treatment up to treatment week 48)
- Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.(Follow-up week 24)
- Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)(Baseline, end of treatment, follow-up week 24)
- Number of Participants With Adverse Events(Throughout entire study, at end of treatment and follow up week 24)