Back to resultsNASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients (NASVAC)
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
NASVAC
Pegylated interferon alpha 2b
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring NASVAC, Pegylated Interferon-2b, CHB
Eligibility Criteria
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.
Sites / Locations
- Farabi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NASVAC
Pegylated interferon alpha 2b
Arm Description
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
Outcomes
Primary Outcome Measures
Number of study participants with virological and or biochemical response as a measure of efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT01374308
First Posted
June 12, 2011
Last Updated
December 11, 2012
Sponsor
Clinical Research Organization, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT01374308
Brief Title
NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients
Acronym
NASVAC
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Organization, Dhaka, Bangladesh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
NASVAC, Pegylated Interferon-2b, CHB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NASVAC
Arm Type
Experimental
Arm Description
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.
Arm Title
Pegylated interferon alpha 2b
Arm Type
Active Comparator
Arm Description
Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks
Intervention Type
Biological
Intervention Name(s)
NASVAC
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alpha 2b
Other Intervention Name(s)
Pegasys, Pegintron, Pegin, Optipeg, Peghebron
Intervention Description
Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks
Primary Outcome Measure Information:
Title
Number of study participants with virological and or biochemical response as a measure of efficacy
Time Frame
At week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamun A Mahtab, MSc MD FACG
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farabi General Hospital
City
Dhaka
ZIP/Postal Code
1207
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
30133478
Citation
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.
Results Reference
derived
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NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients
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