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A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)

NCT02327416 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-08-15

No results posted yet for this study

Summary

This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to assess the efficacy and safety of combination and sequential treatment with Y peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides experienced. Patients were randomized to one of 3 groups to receive different antiviral treatment.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Y peginterferon alfa-2b

In arm 2 and 3, Y peginterferon alfa-2b is used for 96 weeks

DRUG

Granulocyte-macrophage colony stimulating factor

In arm 3, Granulocyte-macrophage colony stimulating factor is used for 48 weeks intermittently

DRUG

Entecavir and or adefovir dipivoxil

In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    collaborator INDUSTRY

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qin Ning, Doctor · 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
2014-10-31
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • China

Study Locations

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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 NCT02327416 on ClinicalTrials.gov