RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,150
- 试验地点
- 24
- 主要终点
- Sustained virological Response (SVR)
研究概览
简要总结
WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.
详细描述
The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48.
A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)
- •Patients with HCV genotype 2 or 3
- •Age 18-70 years
- •Naïve patients or previously treated only with standard interferon monotherapy
- •Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment
排除标准
- •Previous treatment with ribavirin
- •Cirrhosis (CHILD PUGH B and C)
- •Evidence of Hepatocellular carcinoma
- •Pregnancy
- •Retinopathy class I or II
- •Alcohol consumption > 40 gr/day
- •Chronic cardiac or respiratory diseases
- •HIV or HBsAg or HDV positivity
- •Hemoglobin < 8.5 gr/dL
- •WBC < 3.500/mm3
- •PLT < 80.000/mm3
研究组 & 干预措施
Arm A
Patients enrolled in Arm A will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 1000 mg/day for patients with a body weight < 75 kg or 1200 mg/day for those with a body weight > 75 kg.
Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm A), whereas those without RVR will be treated for 24 weeks (Arm A)
干预措施: Peginterferon alpha-2a + Ribavirin (Drug)
Arm B
Patients enrolled in Arm B will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day.
Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm B), whereas those without RVR will be treated for 48 weeks (Arm B)
干预措施: Peginterferon alpha-2a + Ribavirin (Drug)
结局指标
主要结局
Sustained virological Response (SVR)
时间窗: 6 months after the end of treatment
The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR).
次要结局
- Rapid virological response (RVR)(On treatment week 4)
研究者
Alessandra Mangia
MD
Casa Sollievo della Sofferenza IRCCS