EUCTR2019-001139-30-BG进行中（未招募）1 期
A SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY STUDY OF RO7049389 IN: (1) SINGLE- (WITH OR WITHOUT FOOD) AND MULTIPLE- (WITH MIDAZOLAM) ASCENDING DOSES IN HEALTHY VOLUNTEERS; (2) PATIENTS CHRONICALLY INFECTED WITH HEPATITIS B VIRUS (3) PATIENTS WITH CHRONIC HEPATITIS B
F. Hoffman-La Roche Ltd.0 个研究点目标入组 192 人开始时间: 2019年5月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
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
- •- Adult male and female patients, 18 to 60 years of age, inclusive
- •- Positive test for HBsAg or HBV DNA or positive HBeAg for more than 6 months prior to screening.
- •- HbsAg >250 IU/mL at screening
- •- For Cohorts only enrolling NUC-suppressed CHB patients (e.g., POM Cohort A), patients must qualify for the following criteria: a). Patients treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for =12 months. Patients must be on the same NUC therapy for at least 3 months before screening. b). At least one result showed HBV DNA <60 IU/mL at least 6 months prior to screening; and HBV DNA <20 IU/mL at screening by Roche Cobas assay. c). ALT =2 x ULN at screening and at Day -1 (can be checked by local lab result).
- •- For Cohorts only enrolling anti-HBV treatment-naïve and immune-active patients (e.g.,POM Cohort B and Cohort C), patients must qualify for the following criteria: a). Previous anti-HBV treatments for <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose. b). HBV DNA at screening =2 x 104 IU/mL for HBeAg positive patients, or ?2 x 103 IU/mL for HbeAg negative patients. c). ALT at screening between 1–5 x ULN and ALT <5 x ULN at Day -1 (can be checked by local lab result).
- •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 55
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History or other evidence of bleeding from esophageal varices.
- •- Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy.
- •- one or more of the following laboratory abnormalities at screening:
- •- Total serum bilirubin > ULN (exception Gilbert’s disease)
- •- International normalized ratio (INR) >1.1 ULN.
- •- Serum albumin < 3.0 g/dL (<30 g/L).
- •- Platelet count <140,000 cells/mm3
- •- Hemoglobin <12 g/dL (females) or <13 g/dL (males).
- •- White blood cell count <2500 cell/mm3.
- •- Neutrophil count <1500 cell/mm3 (<1200 cell/mm3 if considered a physiological variant in a patient of African descent).
- •- Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein (AFP) =100 mg/mL. If AFP >ULN, absence of mass/findings suspicious for HCC must be demonstrated by ultrasound or CT or MRI within the screening period.
研究者
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