Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Number of Participants With End Treatment Response
研究概览
简要总结
Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.
详细描述
A multicenter, phase IV, open labeled, single arm study was conducted. Total 110 patients were screened for recruitment. Out of which 67 subjects met the inclusion criteria, 3 failed to give the informed consent and were excluded. The final sample size of the study was 64 patients. The duration of study was August 2010 to September 2013. Peginterferon alfa-2a 180µg 20kDa (Unipeg®) solution for injection was administered as single dose sub-cutaneous once weekly for 24 weeks to patients with genotype 3 and 48 weeks in patients with genotype 1 at the site of recruitment. Ribavirin (Ribazole) orally were given in divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). Quality of life related Physical Component Score (PCS) & Mental Component Score (MCS) were measured through Health-Related Quality of Life (HRQOL) Questionnaire (SF-36). The SF-36 questionnaire was completed for all patients during their evaluations before treatment, at 4 weeks, at the end of treatment and at 24 weeks after completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed consent
- •Treatment naïve patients
- •Serological evidence of hepatitis C infection by an anti-HCV antibody test
- •HCV positive by PCR
- •Genotype 1,2 and 3
- •Participants were the resident of city where he /she enrolled at their respective centre
- •No evidence of liver cirrhosis
- •No other significant hepatic or systemic disease
- •No evidence of hepatic encephalopathy
- •Normal thyroid functions (By testing TSH)
- •Adequate bone marrow, liver and renal functions test
- •Hematology: ANC≥1,000/mm3, Platelet count ≥100,000 mm3, Hemoglobin≥11.0g/dl in female and ≥ 12.0 g/dl in male
- •Blood Chemistry: Total Bilirubin≤2.0mg/dl, AST and ALT <3 times normal
- •Creatinine Clearance >50 ml/min
- •Proteinuria: ≤ 0.5 g per 24h.
- •Prothrombin Time or partial-thromboplastin time if ≤1.5 times the upper limit of the normal range.
排除标准
- •Unable to give consent
- •Prior treatment for Hepatitis C
- •Co-infection with HBV and HCV
- •Iron overload
- •Other Genotypes e.g. 4, 5, 6 with their sub-types
- •Pregnant and lactating women
- •History of medical condition associated with chronic liver disease other than CHC (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
- •Uncontrolled Hypertension
- •Uncontrolled Diabetes
- •Severe Depression
- •Clinically significant cardio-vascular disease
- •Symptomatic peripheral vascular disease
- •Oral or parenteral anticoagulants or anti platelet agents
- •History of systemic anti-viral therapy at least three months prior to first dose of study medication
研究组 & 干预措施
PegInterferon alfa-2a and Ribavirin
PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
干预措施: Peginterferon alfa-2a (Drug)
PegInterferon alfa-2a and Ribavirin
PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants With End Treatment Response
时间窗: Upto 48 weeks
To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin
Number of Participants With Sustained Virological Response (SVR)
时间窗: Post treatment Week 24
To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR
次要结局
- Number of Participants Who Reported Adverse Events(Upto 48 weeks)