NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients
NCT ID: NCT01374308
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2011-06-30
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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
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
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Clinical Research Organization, Dhaka, Bangladesh
OTHER
Responsible Party
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Principal Investigators
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Mamun A Mahtab, MSc MD FACG
Role: PRINCIPAL_INVESTIGATOR
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Locations
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Farabi General Hospital
Dhaka, , Bangladesh
Countries
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References
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Al Mahtab M, Akbar SMF, Aguilar JC, Guillen G, Penton E, Tuero A, Yoshida O, Hiasa Y, Onji M. Treatment of chronic hepatitis B naive patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III clinical trial). PLoS One. 2018 Aug 22;13(8):e0201236. doi: 10.1371/journal.pone.0201236. eCollection 2018.
Other Identifiers
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NASVAC01
Identifier Type: -
Identifier Source: org_study_id