NL-OMON30611尚未招募3 期
A randomized, open-label, controlled, multi-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a monotherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB. - Telbivudine study in treatment naïve patients with HBeAg-positive CHB
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, at least 18 years of age.
- •2. Documented Cronic Hepatitis B (CHB) defined by all of the following:
- •*Clinical history compatible with CHB
- •*Detectable serum HBsAg at the Screening visit and at least 6 months prior
- •*HBeAg-positive at the Screening visit
- •*HBeAb-negative at the Screening visit
- •*Documented history of evidence of chronic liver inflammation,
- •*Elevated serum ALT level (1.3 * 10 x upper limit of normal (ULN)) at screening
- •*Serum HBV DNA level * 6 log10 copies/mL (central lab), at screening
- •*Documented chronic liver inflammation on previous liver biopsy within the previous 24 months
排除标准
- •1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients.
- •2. Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
- •3. Current or passed use of excluded drug therapy e.g. other investigational therapy, immunomodulatory treatment, nucleoside or nucleoitide therapy
- •4. Medical condition requiring prolonged use of corticosteroids, hepatotoxic drugs or nephrotoxic drugs.
- •5. Alcohol or illicit drug abuse within the preceding 2 years
- •6. Patient is on thyroid therapy and dose is not stable for at least 5 weeks prior to Visit 2/Baseline
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