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临床试验/ISRCTN15803686
ISRCTN15803686进行中(未招募)2 期

A phase 2 open-label trial to evaluate safety, efficacy, tolerability, and pharmacodynamics of a combination of JNJ-73763989, nucleos(t)ide analogs, and a PD-1 inhibitor in chronic hepatitis B patients

Janssen-Cilag International N.V.0 个研究点目标入组 37 人开始时间: 2022年5月24日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
37

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

性别
All

入选标准

  • 1. Participants must have chronic hepatitis B virus (HBV) infection
  • 2. Participants must have fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (KpA) or a liver biopsy result classified as metavir F0-F2

排除标准

  • 1. Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (Hepatitis E antibody IgM) or human immunodeficiency virus type-1 (HIV-1) or human immunodeficiency virus type-2 (HIV-2) infection (laboratory confirmed) at screening
  • 2. History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices
  • 3. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
  • 4. Participants with personal/familial history/indicative of immune-mediated disease risk

研究者

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