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

December 11, 2012 updated by: Clinical Research Organization, Dhaka, Bangladesh

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1207
        • Farabi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of study participants with virological and or biochemical response as a measure of efficacy
Time Frame: At week 96
At week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Organization, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 12, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASVAC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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