NCT04289987已完成2 期
A Randomized, Double-blinded, Placebo-controlled, Parallel, Multicenter, Phase 2b Study to Evaluate the Efficacy and Safety of CVI-HBV-002 in Patients With Chronic Hepatitis B Taking Tenofovir
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 18
- 主要终点
- Evaluation of Mean Change in HBsAg(log10 IU/mL)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.
详细描述
A randomized, double-blinded, placebo-controlled, parallel, multicenter, phase 2b study to evaluate the efficacy and safety of CVI-HBV-002 in patients with chronic hepatitis B taking Tenofovir disoproxil fumarate/Tenofovir disoproxil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between 19 to 60 years of age
- •Those who have been diagnosed as chronic hepatitis B patients (e.g.HBsAg positive detected for 6 months or more)
- •Started treatment with Tenofovir Disoproxil Fumarate(TDF) or Tenofovir Diproxil(TD), oral HBV antiviral agent, for 6 months to 5 years.
- •HBsAg ≥ 100 IU/mL, HBV DNA ≤ 100 IU/mL at screening
- •HBV DNA ≤ 2000 IU/mL at screening
- •ALT ≤ Upper Limit of Normal) x 2 at screening
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
排除标准
- •Patients with other hepatic disease other than chronic hepatitis B(e.g., hemochromatosis, Wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis, alpha-1 antitrypsin deficiency, etc)
- •If any of the following laboratory tests were found at screening
- •Total bilirubin > Upper Limit of Normal x 2
- •Prothrombin time delayed more than 3 seconds than normal
- •Serum Albumin < 30 g/L (3 g/dL)
- •Hemoglobin < 9.0 g/dL eGFR < 60 mL/min (Cockcroft-Gault)
- •Absolute neutrophil count (ANC) < 1.5 x 10^9 /L (1500 /mm3)
- •Platelet count < 100 x 10^9 /L (100 x 10^3 /mm3)
- •Serum creatinine > 1.5 mg/dL
- •Serum amylase > 2 x ULN and Lipase > 2 x ULN
- •A history of ascites, jaundice, varicoses vein bleeding, hepatic encephalopathy, or other signs of liver failure
- •Treated with oral antiviral agents or interferon therapy other than TDF(or TD)
- •In case of receiving nephroxic drugs(Aminoglycosides, Amphotericin B, NSAIDs, etc.) within 14 days prior to screening
- •When hepatotoxic drugs(Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone, etc.) are administered within 14 days prior to screening
- •Patients with active bacterial, viral or fungal infections requiring systemic treatment
- •Patients diagnosed with Alpha-fetoprotein (AFP) >50 ng/mL or with Hepatocellular Carcinoma (HCC) in screening
- •Of those who have received immunosuppressive drugs within 6 months prior to screening, patients suspected of having decreased immunity by the judgment of the Investigator
- •Patients who have received high dose (prednisone 20mg or more*) systemic corticosteroids for a long period of time(consecutive 14 days or longer) within 3 months before screening (at the discretion of the investigator in case of local corticosteroids)
- •* Corresponding to 125 mg of cortisone, 100 mg of hydrocortisone, 20 mg of prednisone, 16 mg of methylpreprednisolone, 16 mg of triamsynolone, 3 mg of dexamethasone and 2.4 mg of betametasone.
- •Patients who have been diagnosed with malignant tumors within 5 years before screening, or who have recurred malignant tumors(in case of benign tumors, if the Investigator considers that the progress of the clinical trial is not affected during the clinical trial)
- •Organ transplantation recipients
- •Patients with serious illnesses, such as heart failure, renal failure, and pancreatitis, other than liver disease
- •Patients with a history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring treatment or unstable angina)
- •Patients with seizure disorders who require anticonvulsant therapy
- •HbA1c>7.5%
- •SBP≥140mmHg or DBP≥90mmHg
- •Patients infected with hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
- •A hypersensitivity or anaphylactic reaction to the components of the clinical trial drug or HBV vaccine components
- •Continued drinking(>21 units/week, 1 unit = 10g of pure alcohol) or alcohol dependence
- •Pregnancy or breastfeeding, or cannot agree with the approved method of contraception of the patient and partner during the clinical trial(e.g., infertility surgery, intrauterine contraceptive, oral contraceptive and concomitant use of diaphragm or condom, other hormonal delivery systems and concomitant use of diaphragm or condom)
- •Patients who are concerned about the deterioration of daily function due to mental illness or who cannot understand the purpose and method of this trial
- •Patient who has potential to severe febrile or systemic reaction
- •Patients who are scheduled to participate in other clinical trials after enrolling in this trial, or have participated in other clinical trials within 3 month of enrollment in this trial
- •Others those who are considered to be difficult to perform the clinical trial by the judgment of the Investigator
结局指标
主要结局
Evaluation of Mean Change in HBsAg(log10 IU/mL)
时间窗: at week 48 from baseline
To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 48 versus Baseline
次要结局
- Evaluation of Mean changes in serum HBsAg(log 10 IU/mL)(at week 24 from baseline)
- Proportion assessment of Participants With Virologic breakthrough(Baseline to week 48)
- Incidence assessment of Treatment-Emergent Adverse Evnent(Baseline to Week 48)
- Proportion assessment of Participants With HBsAg seroconversion(at weeks 24 and 48)
- Proportion assessment of Participants With HBeAg loss(at Weeks 24 and 48)
- Proportion assessment of Participants With HBsAg loss(at weeks 24 and 48)
- Proportion assessment of Participants With HBeAg seroconversion(at weeks 24 and 48)
- Evaluation of changes in HBV specific T cell immunity(at weeks 12 and 24 from baseline)
研究者
研究点 (18)
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