EUCTR2021-002450-81-ES进行中（未招募）1 期
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection. - The PENGUIN-2 Study
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
- 102
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
- •A01. Adult male or female participants =18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
- •M02. Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
- •A03. Participants must have chronic HBV infection.
- •M04. Participants must have a body mass index between 18.0 and 35.0 kg/m2, extremes included.
- •A05. Participants must sign a Master ICF and must sign the ICF specific for this intervention cohort, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Please refer to the study protocol for a full list of inclusion criteria.
- •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 97
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening.
- •A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening.
- •M03. History or evidence of clinical signs or symptoms of hepatic decompensation.
- •M04. Participants with evidence of liver disease of non-HBV etiology.
- •A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities.
- •Please refer to the study protocol for a full list of exclusion criteria.
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