Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,430
- 主要终点
- Number of Participants Achieving SVR (Stage 2)
研究概览
简要总结
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.
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
- •Treatment-naïve patients with chronic hepatitis C
- •Adults (>18 years of age)
- •Prescribed Pegetron Redipen
- •Must meet all requirements for treatment with Pegetron Redipen
- •Must be able to obtain reimbursement of medication through private or provincial coverage
排除标准
- •Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
- •HIV antibody positive
- •Post liver transplant patients
- •Any other exclusion criteria as per the product Monograph
研究组 & 干预措施
Stage 1 Participants
Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
干预措施: PegIFN-2b (Biological)
Stage 1 Participants
Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
干预措施: Ribavirin (Drug)
Stage 2 Participants
Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
干预措施: PegIFN-2b (Biological)
Stage 2 Participants
Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants Achieving SVR (Stage 2)
时间窗: Up to 72 weeks
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
时间窗: Up to 72 weeks
This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
时间窗: Up to 62 weeks
This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
时间窗: Up to 72 weeks
This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
次要结局
- Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)(Up to 72 weeks)
- The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)(Up to 72 weeks)
- Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)(Up to 48 weeks)
- Number of Participants Achieving SVR by Viral Load (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)(Up to 62 weeks)
- Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving SVR by Gender (Stage 1)(Up to 72 weeks)
- The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)(Up to 62 weeks)
- Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving RVR Who Achieved SVR (Stage 2)(Week 4)
- Number of Participants Achieving EVR Who Achieved SVR (Stage 2)(Week 12)
- Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)(Up to 72 weeks)
- The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)(Up to 62 weeks)
- The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)(Up to 62 weeks)
- Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving SVR by Weight (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving EVR (Stage 1)(From Week 10 to Week 14)
- Number of Participants Achieving SVR by EVR Type (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving SVR by Race (Stage 1)(Up to 72 weeks)
- Number of Participants With End of Treatment (EOT) Response (Stage 1)(Up to 48 weeks)
- Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)(Up to 72 weeks)
- Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)(Week 12)
- Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)(Up to 72 weeks)
- Number of Participants Achieving RVR by Race (Stage 2)(Week 4)
- Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)(Week 4)
- Relapse Rate by HCV Genotype (Stage 1)(Up to 48 weeks)
- Number of Participants Achieving SVR by Race (Stage 2)(Up to 72 weeks)
- Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)(Week 12)
- Number of Participants Achieving RVR by Weight (Stage 2)(Week 4)
- Number of Participants Achieving EVR by Weight (Stage 2)(Week 12)
- Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)(Up to 72 weeks)
- Number of Participants Achieving RVR by Gender (Stage 2)(Week 4)
- Number of Participants Achieving EVR by HIV Status (Stage 2)(Week 12)
- Number of Participants Achieving SVR by HIV Status (Stage 2)(Up to 72 weeks)
- Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)(Up to 48 weeks)
- Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)(Week 4)
- Number of Participants Achieving EVR (Stage 2)(Week 12)
- Number of Participants Achieving EVR by Race (Stage 2)(Week 12)
- Number of Participants Achieving SVR by Weight (Stage 2)(Up to 72 weeks)
- Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)(Week 4)
- Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)(Up to 72 weeks)
- Number of Participants Achieving EVR by Gender (Stage 2)(Week 12)
- Number of Participants Achieving SVR by Gender (Stage 2)(Up to 72 weeks)
- Number of Participants Achieving RVR by HIV Status (Stage 2)(Week 4)
- Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)(Week 12)