PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 主要终点
- Overall incidence of adverse events and adverse drug reactions.
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
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 diagnosed with chronic hepatitis C
- •Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
- •Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
排除标准
- •Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
- •Interferon-naïve patients with low viral load
- •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: Rebetol (ribavirin; SCH 18908) (Drug)
Arm 1
Overall study population.
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Drug)
结局指标
主要结局
Overall incidence of adverse events and adverse drug reactions.
时间窗: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients
时间窗: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
时间窗: Assessed at 24 weeks post-treatment
次要结局
- Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.(End of treatment and 24 weeks after end of treatment)