PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,077
- 主要终点
- Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.
研究概览
简要总结
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C.
- •Patients are serogroup 1(genotype I (1a) or II (1b)).
- •The HCV-RNA level in the blood is more than 10^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method
排除标准
- •Patients with a history of hypersensitivity to test drugs or other interferon preparations
- •Patients with a history of hypersensitivity to biological products, such as vaccines
- •Patients being treated with Shosaikoto
- •Patients with autoimmune hepatitis
- •Pregnant women, women who may be pregnant, and nursing mothers
- •Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
- •Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
- •Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
- •Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
- •Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
- •Patients with serious hepatic dysfunction
- •Patients with autoimmune hepatitis
研究组 & 干预措施
Arm 1
Overall study population
干预措施: peginterferon alfa-2b (Drug)
Arm 1
Overall study population
干预措施: ribavirin (Drug)
结局指标
主要结局
Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.
时间窗: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Sustained virologic response rate and improvement of ALT (alanine transaminase).
时间窗: Assessed at the end-of-treatment and at 24 weeks post-treatment.
Overall incidence of adverse events and adverse drug reactions.
时间窗: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
次要结局
未报告次要终点