NCT03357822

A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B

A Real-World Study of Sequential Combination Therapy With Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the prospective real-world study is to evaluate whether sequential combination therapy with pegylated interferon plus entecavir/tenofovir could induce higher rates of HBsAg loss in nucleoside-treated patients with chronic hepatitis B compared to continuous nucleoside treatment.

Detailed description

Patents who were treated with NA at least one year and achieved hepatitis B virus (HBV) DNA suppression and HBsAg level\<3000 international unit (IU) /mL are enrolled in this study, they are assigned into two groups, in group I, patients will receive pegylated interferon plus entecavir/tenofovir for 48/72/96 weeks, in group II, patients will receive entecavir/tenofovir for 96 weeks. HBsAg loss rates at the end of treatment and sustained response at the end of follow up will be evaluated.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Pegylated interferon	180ug Pegylated interferon is injected subcutaneously once a week
DRUG	Entecavir	0.5mg entecavir is orally taken every day
DRUG	Tenofovir disoproxil fumarate	300mg tenofovir is orally taken every day

Timeline

• Start date: 2018-01-25
• Primary completion: 2022-01-25
• Completion: 2022-07-25
• First posted: 2017-11-30
• Last updated: 2018-04-25

Locations

12 sites across 1 country: China