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

NCT03164889 | Terminated DMC

• 1 other identifier: 首发2014-2-5033
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic hepatitis B, antiviral treatment

Outcome Measures

Primary Outcomes (1)

• Rate of HBsAg loss

  48 weeks after therapy

Secondary Outcomes (2)

• Rate of HBeAg loss

  48 weeks after therapy

• HBVDNA undetectable rate

  48 weeks after therapy

Study Arms (2)

ETV+GM-CSF

EXPERIMENTAL

Entecavir (ETV) plus Granulocyte Macrophage-colony Stimulating Factor (GM-CSF). ETV was given 0.5mg/d, oral; GM-CSF was given 100ug, the 3th, 4th, 5th day at week1, 4, 12, 24, 48, subcutaneous injection.

Drug: Granulocyte Macrophage-colony Stimulating Factor; Drug: Entecavir

ETV monotherapy

ACTIVE COMPARATOR

As standard antiviral therapy, Entecavir was given 0.5mg/d, oral.

Drug: Entecavir

Interventions

Granulocyte Macrophage-colony Stimulating Factor DRUG

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

Also known as: GM-CSF

ETV+GM-CSF

Entecavir DRUG

Antiviral drug for hepatitis b virus (HBV)

Also known as: ETV

ETV monotherapy; ETV+GM-CSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg positive for more than 6 months
• HBeAg positive
• ALT≥80U/L or inflammation score ≥2 of histological examination

You may not qualify if:

• History of drug allergy to GM-CSF
• coinfection with HCV, HIV, HAV, HEV
• liver cirrhosis or CHILD score \>7
• diagnosis of hepatocellular carcinoma or AFP\>100ng/ml
• Allergic thrombocytopenic purpura

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

302 Military Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Colony-Stimulating Factors; Granulocyte-Macrophage Colony-Stimulating Factor; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ping Zhao, Director

  302 Military Hospital, Beijing, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: May 24, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2021
• Last Updated: March 24, 2022

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)