NCT03332329

Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients

Efficacy and Safety of Combination Therapy With Entecavir, Peginterferon Alfa-2b and Immunomodulators in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Qin Ning · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the prospective study is to determine whether combination/ sequential therapy with Entecavir, Peginterferon alfa-2b and immunomodulators Granulocyte Macrophage Colony Stimulating Factor (GMCSF)+vaccine could induce HBsAg loss in chronic hepatitis B patients with maintained Hepatitis B Virus (HBV) DNA suppression on long-term nucleoside or nucleotide analogue (NA).

Detailed description

Patents who were treated with NA at least one year and achieved HBV DNA suppression are enrolled in this study, they will receive Entecavir (ETV) for 60 weeks, HBV vaccine (60ug/month, every four weeks) for 24 weeks, GMCSF (75 μg/day, first 5 days each month, subcutaneous) from baseline to week 16 and from week 60 to week 84, and Y peginterferon alfa-2b (180 μg/week, subcutaneous) from week 16 to week 108.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Entecavir	Entecavir is used for 96 weeks
DRUG	Granulocyte Macrophage Colony Stimulating Factor	Granulocyte-macrophage colony stimulating factor is used intermittently from baseline to week 16 and from 60 to week 84
DRUG	Y peginterferon alfa-2b	Y peginterferon alfa-2b is used for 96 weeks
DRUG	HBV vaccine	60ug HBV vaccine is used every four week for 24 weeks

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2017-11-06
• Last updated: 2017-11-06