Phase IIII Study of a Therapeutic Vaccine Candidate Containing Hepatitis B Virus (HBV) Core Antigen (HBcAg) and HBV Surface Antigen (HBsAg) for Treatment of Patients With Chronic HBV Infection
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of study participants with virological and or biochemical response as a measure of efficacy
研究概览
简要总结
The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).
详细描述
To collect and assess data on the therapeutic potential of the NASVAC in CHB patients regarding:
Reduction of the serum HBV DNA levels. Reduction in the levels of alanine aminotransferase (ALT) Clearance of hepatitis B e antigen (HBeAg) Negativation or lowering of HBsAg Anti-HBsAg/anti-HBeAg seroconversion
An additional objective of this study is to reconfirm the safety of NASVAC in CHB patients that has previously been shown by us in Phase I-II clinical trial in CHB patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg+ serology for more than 6 months before the beginning of the treatment.
- •In the last six months, according to HBeAg serostatus, for:
- •HBeAg (-) patients, with a) baseline HBV DNA ≥ 103 and b) raised serum ALT (x >1 ULN) or significant hepatic necroinflammation and/or fibrosis (HAI-NI>4 and/or HAI-F >2) or liver stiffness >7.2 KPa.
- •HBeAg (+) patients, with a) baseline HBV DNA ≥ 104 and b) and raised serum ALT (x >1.5 ULN) or significant hepatic necroinflammation and or fibrosis (HAI-NI>4 and/or HAI-F >2) or liver stiffness >7.2 KPa.
- •Patients of both sex from 18 to 60 years-old
- •No specific hepatitis B treatment at least for 6 months previous to the inclusion
- •Voluntary signed informed consent to participate in the trial
排除标准
- •Condition of HBV asymptomatic carrier or cirrhosis or patients with primary hepatocellular carcinoma
- •Positive serological markers for hepatitis C
- •Positive serological markers for HIV
- •Previous specific anti-hepatitis B treatment in the last 6 months.
- •Critically ill patient history of heart or renal failure, hypertension, hyperthyroidism, epilepsy, immunodeficiency diseases, malignancies or any non-controlled systemic disease.
- •Pregnancy or nursing women. Women in fertile age without any contraceptive methods.
- •Known severe allergic conditions (degree III or IV asthma, urticaria, dermatitis, bronchitis, etc. or hypersensitivity to any of the ingredients present in the preparation).
- •Severe psychiatric dysfunction or another limitation that prevents the patient's consent.
- •History of Autoimmune diseases (such as SLE, rheumatoid arthritis, multiple sclerosis, non controlled diabetes mellitus type 1)
- •History of other hepatic diseases of different etiology (such as alcoholism, autoimmune hepatitis, drug induced hepatitis, Wilson's diseases, hemochromatosis)
- •History of immune suppressive disorder or administration of immune suppressive-immune modulator drugs (including steroids) during or in the 6 months previous to the study.
- •Very high transaminase levels at the beginning of treatment (ALT over 500 U/L) suggesting a not stable disease with risk for patient's health or acute flares over 15 times the upper limit of normality.
研究组 & 干预措施
NASVAC
NASVAC will be administered every 2 weekly intra-nasally at a dose of 100 micro grams for 5 times followed by every 2 weekly administration of 100 micro grams intra-nasally plus 100 micro grams subcutaneously.
干预措施: NASVAC (Biological)
Pegylated interferon alpha 2b
Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks
干预措施: Pegylated interferon alpha 2b (Drug)
结局指标
主要结局
Number of study participants with virological and or biochemical response as a measure of efficacy
时间窗: At week 96
次要结局
未报告次要终点