EUCTR2017-001647-12-PL进行中（未招募）1 期
A Phase 2a, Open-Label, Study Evaluating the Safety and Anti-Viral Activity of ARB-001467 in Non-Cirrhotic, HBeAg-Negative Subjects with Chronic HBV Infection (Genotype A or B) in Combination with PEG-IFN a-2a and Tenofovir Disoproxil Fumarate
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Chronic HBV infection as documented at screening by either:
- •a. Positive HBsAg, or hepatitis B virus e-antigen (HBeAg; negative or positive) or HBV-DNA at least 6 months prior to screening; OR
- •b. Historical liver biopsy consistent with chronic HBV infection with documentation available at screening
- •2. Subject must be HBV-DNA(+) with a HBV-DNA =1000 IU/mL and either treatment-naive or treatment-experienced, defined as follows:
- •a. Treatment naïve subjects: Subjects have never received nucleos(t)ide analogue (NA) therapies including, but not limited to, TDF, entecavir, telbivudine, or lamivudine and/or interferon-alpha; OR
- •b. Treatment experienced subjects: Subjects may have previously had NA therapies (including, but not limited to, TDF, entecavir, telbivudine, or lamivudine) and/or interferon-alfa therapy, but must have discontinued treatment at least 6 months prior to screening
- •3. Quantitative HBsAg =1000 IU/mL and =10000 IU/mL at the Screening Visit
- •4. HBV genotype A or B at the screening visit
- •5. Interleukin (IL)28B CC Genotype
- •6. HBeAg-negative at the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known co infection with any of the following: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), or Hepatitis E virus (HEV).
- •2. Any known pre existing medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings.
研究者
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