JPRN-jRCT2071200049已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Cotrolled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)ide Analog in Participants Co-infected with Hepatitis B and Hepatitis D Virus - REEF-D
akama Takahiro0 个研究点目标入组 190 人开始时间: 2020年10月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
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
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
- •- Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
- •- For Part 1: Hepatitis D RNA (HDV RNA) greater than or equal to (>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values >= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (<=) 10,000 IU/mL at screening or HDV RNA values at screening are <= 100,000 IU/mL
- •- Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
- •- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
- •- Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
- •- Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of >= 140,000 per deciliter (dL) for enrollment into Part-2
排除标准
- •- Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
- •- History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy
- •- Evidence of liver disease of non-HBV/HDV etiology
- •- Signs of hepatocellular carcinoma (HCC)
- •- Significant laboratory abnormalities as defined in the protocol at screening
- •- Participants with a history of malignancy within 5 years before screening
- •- Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
- •- History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
- •- Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
- •- History of or current clinically significant skin disease or drug rash
- •- Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients
- •- Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
- •- Participants who have taken any therapies disallowed per protocol
- •- Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
- •- Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention.
- •- Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
- •- Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)
研究者
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