Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sustained virologic response
研究概览
简要总结
Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (male or female), 18 to 65 years of age, with chronic HCV infection
- •Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
- •Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
- •Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
- •Patients must be serum hepatitis B surface antigen (HBsAg) negative
- •Negative Antinuclear Antibodies (ANA) or titer of < 1:160
- •Serum positive for anti-HCV antibodies and HCV-RNA
- •Abdominal Ultrasound obtained within 3 months prior to entry in the study
- •Electrocardiogram for men aged > 40 years and for women aged > 50 years
- •Normal fundus examination
- •Proper contraception measure throughout the course of treatment and six months later
- •Female patients must not breast feed during therapy
排除标准
- •Patients who previously received interferon
- •HgbA1c > 7.5 or history of diabetes mellitus
- •BMI > 34
- •Women who are pregnant or breast-feeding
- •Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
- •Other causes of liver disease including autoimmune hepatitis
- •Transplant recipients receiving immune suppression therapy
- •Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
- •Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score > 6 or MELD score > 8
- •Absolute neutrophil count < 1500 cells/mm3; platelet count < 135,000 cells/mm3; hemoglobin < 12 g/dL for women and < 12.5 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN
- •Hypothyroidism or hyperthyroidism not effectively treated with medication
- •Alcohol consumption of > 40 grams per day or an alcohol use pattern that will interfere with the study
- •History or other clinical evidence of significant or unstable cardiac disease
- •History or other clinical evidence of chronic pulmonary disease associated with functional impairment
- •Serious or severe bacterial infection(s)
- •History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
- •History of uncontrolled severe seizure disorder
- •History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
- •Patients with clinically significant retinal abnormalities
- •Subjects receiving vitamin D for any other medical condition.
- •Subjects with significant active rheumatologic or orthopaedic conditions.
研究组 & 干预措施
Standard of care
Group A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: pegylated interferon + ribavirin (Drug)
Triple therapy
Group B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
干预措施: vitamin D +pegylated interferon + ribavirin (Drug)
结局指标
主要结局
Sustained virologic response
时间窗: 72 weeks
Undetectable HCV-RNA 24 weeks after end of treatment.
次要结局
- rapid virologic response(4 weeks)
- End-of-treatment response(48 weeks)
- Adverse events(72 weeks)
- early virologic response(12 weeks)