Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The Decline of Participants Serum HBV DNA values for both study arms at each study.
研究概览
简要总结
Hepatitis B virus (HBV) leads to life-threatening disease like liver failure and liver cancer. For most, a cure is unattainable as current HBV antiviral therapy (using nucleoside analogues) are not able to clear the virus from their liver. While HBV treatments are typically administered alone (monotherapy), this study will explore the use of Ribavirin in combination with standard therapy to enhance current treatment regimens. Ribavirin is commonly used to treat Hepatitis C Virus (HCV) but there is evidence that Ribavirin also induces immune effects that are beneficial in HBV treatment. The aim of this study is to determine whether combination of Ribavirin and a nucleoside analog is more effective compared to nucleoside analog treatment alone. Enrolled patients will be followed for treatment response according to standard clinical and virological tests, as well as immune response to HBV. Our ultimate goal is to find a more effective treatment and improve health outcomes for persons living with HBV.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks
- •HBV DNA level >20,000 IU/mL
- •≥ 18 years of age
排除标准
- •Willingness and ability to sign an informed consent
- •HBV nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing
- •HIV and other immune compromising condition (e.g. cancer with the exception of non-invasive cutaneous malignancy, autoimmune condition) or therapy (i.e. systemic steroids, chemotherapy)
- •HCV co-infected
- •Cirrhosis (defined by biopsy criteria or as >18.4 kilopascal (kPa) by transient elastography)
- •Creatinine Clearance <60 ml/min
- •Baseline hemoglobin <130 g/L in males and <120 g/L in females
- •Unwilling or unable to use contraception (unless confirmed surgical sterilization)
- •Pregnancy confirmed by blood test
研究组 & 干预措施
Group 1
Tenofovir (TDF) 300 mg po once a day (OD)
干预措施: Tenofovir (Drug)
Group 2
Tenofovir 300 mg po OD + Ribavirin 400 mg twice a day (BID) if <70kg / 600 mg every (q) in the morning (AM) and 400 mg q in the evening (PM) if ≥70kg
干预措施: Ribavirin (Drug)
Group 2
Tenofovir 300 mg po OD + Ribavirin 400 mg twice a day (BID) if <70kg / 600 mg every (q) in the morning (AM) and 400 mg q in the evening (PM) if ≥70kg
干预措施: Tenofovir (Drug)
结局指标
主要结局
The Decline of Participants Serum HBV DNA values for both study arms at each study.
时间窗: 24 weeks
The absolute decline in HBV DNA and quantitative HBsAg titre will be compared with baseline level at each study visit overall and between study arms (with or without RBV).
次要结局
- Fibroscan score(24 weeks)
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0.(28 weeks)
- Liver enzyme values(24 weeks)