Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 主要终点
- Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
研究概览
简要总结
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.
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
- 否
入选标准
- •Treatment-naïve participants or relapsers to interferon monotherapy
- •Participants with chronic hepatitis C infection
- •At least 18 years of age
- •Must meet the following laboratory criteria:
- •Platelets >=100,000/mm^3
- •Neutrophil count >=1,500/mm^3
- •TSH (thyroid stimulating hormone) within normal limits
- •Hemoglobin >=12 g/dL (females); >=13 g/dL (males)
- •Ex-intravenous drug abusers who are under stable substitution therapy
- •Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
- •Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment
排除标准
- •Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
- •Hypersensitivity to the active substance or to any interferons or to any of the excipients
- •Pregnant women
- •Women who are breast-feeding
- •Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
- •A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months
- •Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance <50 mL/min
- •Coinfection with HIV (Human Immunodeficiency Virus)
- •Autoimmune hepatitis or history of autoimmune disease
- •Severe hepatic dysfunction or decompensated cirrhosis of the liver
- •Pre-existing thyroid disease unless it can be controlled with conventional therapy
- •Epilepsy and/or compromised central nervous system function
研究组 & 干预措施
PegIntron + Rebetol
There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
干预措施: PegIntron (pegylated interferon alfa-2b; SCH 54031) (Biological)
PegIntron + Rebetol
There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
结局指标
主要结局
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
时间窗: End of Follow-up (Week 48 or Week 72, depending on genotype)
Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week
时间窗: Assessed at the end of treatment
Tolerability of the treatment was measured by number of participants with complete treatment.
次要结局
未报告次要终点