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Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients

NCT03164889 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-24

No results posted yet for this study

Summary

Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) could improve survival rate in patients with acute liver failure and obtain higher HBsAg seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB) patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus GM-CSF in patients with CHB compared to ETV monotherapy.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Granulocyte Macrophage-colony Stimulating Factor

The intervention drug was used as an immunomodulator in order to improve rates of HBsAg loss and HBeAg loss.

DRUG

Entecavir

Antiviral drug for hepatitis b virus (HBV)

Sponsors & Collaborators

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Ping Zhao, Director · 302 Military Hospital, Beijing, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-01
Completion
2021-12-01

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 NCT03164889 on ClinicalTrials.gov