MedTrace Logo

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

NCT02360592 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-05-09

No results posted yet for this study

Summary

This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3 groups to receive different antiviral treatment.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

In arm 1, Entecavir is used for 48 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir is used for 8 weeks.

DRUG

Interferon alfa-2b

In arm 2 and 3, interferon alfa-2b is used for 48 weeks

DRUG

Interleukin 2

In arm 3, Interleukin 2 is used for 12 weeks

DRUG

Hepatitis B Vaccine

In arm 3, Hepatitis B Vaccine is used for 48 weeks

Sponsors & Collaborators

  • Beijing Kawin Technology Share-Holding Co., Ltd.

    collaborator INDUSTRY

  • Fujian Cosunter Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qin Ning, Ph.D. M.D. · Department of Infectious Diseases, Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2017-04-30

Countries

  • China

Study Locations

More Related Trials

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 NCT02360592 on ClinicalTrials.gov