NL-OMON33087已完成2 期
A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients - CNIM811B2202
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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. Chronic Hepatitis C Genotype 1
- •2. HCV-RNA should be * 4 x 105 IU/mL at screening.
- •3. Recipient of prior long acting interferon (either as PegIntron, Pegasys or albumin-interferon alpha-2b) and ribavirin (either ribavirin or the ribavirin pro-drug, viramidine) treatment for at least 3 months prior to start study (Visit 1), with documented negative serum HCV RNA on treatment , who subsequently becomes serum HCV RNA positive after stopping treatment (*relapser*). Patients must have been off all treatment for at least 3 months.
- •4. Male and female subjects age 18 to 69 years of age
- •5. Platelets counts > 150,000
排除标准
- •1. Use of any HCV-specific anti-viral medications within 3 months prior to start study 2. Prior receipt of any investigational anti-HCV therapy that is not interferon or ribavirin
- •3. Women of child-bearing potential
- •4. Evidence of cirrhosis at the time of screening
- •5. Evidence of hepatic decompensation
- •6. Evidence of current or past HBV or HIV infection
- •7. History of treatment for depression or mental illness
- •8. Pregnant or lactating females
- •9. Inability to limit alcohol consumption * 35 gm/day
- •10. Current use of illicit drugs
- •11. Oral or intravenous steroid treatment or immunosuppression 3 months prior to screening or anticipated need for such treatment within the entire study period (72 weeks)
- •12. History of clinical evidence of chronic cardiac disease or ECG with clinically significant abnormalities
- •13. Current treatment for hypothyroidism
- •14. Has any of the following laboratory values at screening
- •* Hgb <12 g/dL in males or <11 g/dL in females.
- •* White blood cell count < 3,000/mm3
- •* Absolute neutrophil count (ANC) < 1,500/mm3
- •* Platelet count < 150,000 per mm3
- •* BUN or serum creatinine > ULN (confirmed), or Creatinine clearance < 50 mL/min
- •* Serum amylase or lipase > 2X ULN
- •* Fasting triglycerides > ULN
- •* Patients with total alpha-fetoprotein levels above 500 ng/ml
- •15. Lenticular opacity, which according to the investigator, will require cataract surgery within 12 months
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