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

NCT03013556 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Ruijin Hospital
Phase	Phase 4
Status	UNKNOWN
Enrolment	180
Start date	2016-11
Completion	2021-12-31

Conditions

• Chronic Hepatitis

Interventions

• Group A, TDF
• Group B:TDF then TDF and Peginterferon alfa-2a
• Group C:TDF and Peginterferon alfa-2a then TDF

Primary outcomes

• Number of subjects who achieve HBeAg seroconversion — at 96 week
  The number of subjects with HBeAg seroconversion at week 96 will be measured

Countries

China