NCT03013556

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA\<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

Detailed description

The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA\<10\*5copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.

Conditions

• Chronic Hepatitis

Interventions

Type	Name	Description
DRUG	Group A, TDF	TDF for 96 weeks
DRUG	Group B:TDF then TDF and Peginterferon alfa-2a	Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
DRUG	Group C:TDF and Peginterferon alfa-2a then TDF	Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-12-30
• Completion: 2021-12-31
• First posted: 2017-01-06
• Last updated: 2021-09-22

Locations

8 sites across 1 country: China