NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||nasvac, pegylated interferon alpha 2b|
|Sponsor||Clinical Research Organization, Dhaka, Bangladesh|
|Start date||June 2011|
|End date||June 2013|
|Trial size||160 participants|
|Trial identifier||NCT01374308, NASVAC01|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Number of study participants with virological and or biochemical response as a measure of efficacy
time frame: At week 96
Male or female participants from 18 years up to 60 years old.
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.
|Official title||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|
|Principal investigator||Mamun A Mahtab, MSc MD FACG|
|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.|
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