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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01374308
First received: June 12, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis B
Biological: NASVAC
Drug: Pegylated interferon alpha 2b
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Clinical Research Organization, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Number of study participants with virological and or biochemical response as a measure of efficacy [ Time Frame: At week 96 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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
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
Other Names:
  • Pegasys
  • Pegintron
  • Pegin
  • Optipeg
  • Peghebron

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374308

Locations
Bangladesh
Farabi General Hospital
Dhaka, Bangladesh, 1207
Sponsors and Collaborators
Clinical Research Organization, Dhaka, Bangladesh
Investigators
Principal Investigator: Mamun A Mahtab, MSc MD FACG Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01374308     History of Changes
Other Study ID Numbers: NASVAC01
Study First Received: June 12, 2011
Last Updated: December 11, 2012
Health Authority: Bangladesh: Directorate of Drug Administration

Keywords provided by Clinical Research Organization, Dhaka, Bangladesh:
NASVAC
Pegylated Interferon-2b
CHB

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014