NCT03084250

The Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC

A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai Nanhui Nanhua Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The CHB subjects who are cirrhosis, will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.

Detailed description

This study is a prospective, randomized, open-label study. The CHB subjects who are cirrhosis will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Peginterferon Alfa-2A	180μg/week, 48 weeks; 135μg/week,48weeks
DRUG	Adefovir, entecavir,tenofovir, either of them	Adefovir, entecavir,tenofovir, either of them is ok

Timeline

• Start date: 2017-03-10
• Primary completion: 2023-04-01
• Completion: 2023-12-01
• First posted: 2017-03-20
• Last updated: 2017-05-03

Locations

1 site across 1 country: China