An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The modification of AMH levels
研究概览
简要总结
The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.
详细描述
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 35 years of age at the time of Screening
- •Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug.
- •Females must have negative results for pregnancy tests
- •Chronic HCV-infection prior to study enrollment
- •Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection.
- •Must be able to voluntarily sign and date an informed consent form
- •Liver biopsy within 24 months prior to or during screening demonstrating a Metavir score of 2 or less or an Ishak score of 3 or less or Screening FibroScan® result of ≤ 9.6 kPa;
排除标准
- •Women who are pregnant or breastfeeding
- •Positive test result for HBsAg and HIV Ab
- •Recent history of drug or alcohol
- •HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype.
- •Use of medications contraindicated
- •Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8
- •History of solid organ transplant.
- •Confirmed presence of hepatocellular carcinoma
- •Current use of any investigational or commercially available anti-HCV agents
- •Screening laboratory analyses showing any of the following abnormal laboratory results
研究组 & 干预措施
group treated
this group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks.
干预措施: Ribavirin (Drug)
group treated
this group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks.
干预措施: Ombitasvir-Paritaprevir-Ritonavir (Drug)
group treated
this group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks.
干预措施: Dasabuvir (Drug)
结局指标
主要结局
The modification of AMH levels
时间窗: 48 weeks post treatment
The primary outcome is to evaluate the modification of AMH levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint
次要结局
- Modification of AMH levels(144 weeks)
- Modification of the Estradiol (E2) levels(144 weeks)
- Percentage of participants experiencing miscarriage(144 weeks)
研究者
Prof. Facchinetti Fabio
PRS administrator
University of Modena and Reggio Emilia