MedTrace Logo

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

NCT01374308 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-12-12

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Clinical Research Organization, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Mamun A Mahtab, MSc MD FACG · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374308 on ClinicalTrials.gov