NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients

Chronic Hepatitis B Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01374308
• Other study ID #: NASVAC01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 12, 2011
• Last updated: December 11, 2012
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Clinical Research Organization, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Directorate of Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• 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.

Drug:
• 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

Locations

Country	Name	City	State
Bangladesh	Farabi General Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Organization, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study participants with virological and or biochemical response as a measure of efficacy		At week 96	Yes