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Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

NCT03013556 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-09-22

No results posted yet for this study

Summary

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA\<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

Conditions

  • Chronic Hepatitis

Interventions

DRUG

Group A, TDF

TDF for 96 weeks

DRUG

Group B:TDF then TDF and Peginterferon alfa-2a

Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks

DRUG

Group C:TDF and Peginterferon alfa-2a then TDF

Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Xinxin Zhang · Ruijin 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
2016-11-30
Primary Completion
2021-12-30
Completion
2021-12-31

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 NCT03013556 on ClinicalTrials.gov