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A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs

NCT02894918 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-09-12

No results posted yet for this study

Summary

This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.

The CHB patients with NAs treatment and have achieved HBV DNA \<15 IU/ml、HBeAg \<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml will be randomized into 2 groups:

Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.

Conditions

Interventions

DRUG

Peginterferon alfa-2a

180ug/0.5ml,hypodermic injection once a week

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jia Shang, M.D. · Henan People's 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
2016-09-30
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • China

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 NCT02894918 on ClinicalTrials.gov