CTRI/2017/07/009027尚未招募3 期
A phase IIIB, randomized, open-label study of pegylated interferon alfa-2a in combination with Lamivudine or Entecavir compared with untreated control patients in children with HBeAg-positive Chronic Hepatitis B in the immune-tolerant phase
F HoffmannLa Roche Ltd0 个研究点目标入组 114 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
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
入选标准
- •1. Male or female patients 3â??17 years of age at baseline (or 12 â??17 years of age at baseline in
- •2. Positive for HBsAg and HBeAg for more than 6 months prior to baseline
- •3. Detectable HBV-DNA ( > 10,000 copies/mL [ > 2000 IU/mL]) (as measured by polymerization chain reaction [PCR] or hybridization) on at least 2 occasions one month apart with at least one of the determinations obtained <= 42 days prior to baseline.
- •4. Compensated liver disease (Child-Pugh Class A clinical classification)
排除标准
- •1. Patients who have received investigational drugs or licensed treatments with anti HBV
- •activity (e.g., interferons [IFNs], lamivudine, tenofovir, emtricitabine, adefovir, entecavir,
- •telbivudine, systemic acyclovir, systemic famciclovir) (Exception: Patients who have had a
- •limited [<= 7-day] course of acyclovir for herpetic lesions more than 1 month before the study baseline visit are not excluded.)
- •2. Patients who have participated in any other clinical trial or who have received any
- •investigational drug within 6 months prior to baseline
- •3. Known hypersensitivity to IFN, Pegasys or lamivudine
- •4. History of immunologically mediated disease to include, but not limited to: autoimmune
- •hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus
- •erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or clinical
- •evidence of rheumatoid arthritis
- •5. History of solid organ or bone marrow transplantation
- •6. History or other evidence of severe retinopathy
- •7. History or other evidence of severe illness or any other conditions that would make the
- •patient, in the opinion of the investigator, unsuitable for the study
- •8. Active substance abuse within 6 months prior to screening
- •9. Sexually active females of childbearing potential and sexually active males who are not
- •willing to utilize reliable contraception during treatment and for 90 days following the end of
- •10. Females who are pregnant or who are breastfeeding. (Females of childbearing potential
- •who have a positive urine or serum pregnancy test result within 24 hours of baseline are
研究者
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