Chronic Hepatitis B
Conditions
Keywords
NASVAC, Pegylated Interferon-2b, CHB
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALNASVAC
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.
Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks
Sponsors
Clinical Research Organization, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of study participants with virological and or biochemical response as a measure of efficacy | At week 96 |
Countries
Bangladesh
Outcome results
None listed