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

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital
• Treatments: Antiviral Agents; Entecavir; Molgramostim; Sargramostim

Criteria

Inclusion Criteria:

• HBsAg positive for more than 6 months

• HBeAg positive

• ALT≥80U/L or inflammation score ≥2 of histological examination

Exclusion Criteria:

• 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