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. - 73763989PAHPB2008- OCTOPUS-1

Janssen-Cilag International NV0 个研究点目标入组 44 人开始时间: 2022年2月24日最近更新: 2022年5月16日

研究概览

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•A01. Adult male or female participants =18 (or the legal age of consent in the jurisdiction in which the study is taking place) to <56 years of age.
•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 30.0 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 44
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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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