Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 29 August 2016
• Main ID: NCT02368288
• Date of registration: 14/02/2015
• Prospective Registration: No
• Primary sponsor: Beijing Ditan Hospital
• Public title: Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
• Scientific title: Efficacies of Entecavir Add on Chronic Hepatitis B Patients With HBV DNA Load =1000 Copies/ml After 6 Months Treatment of Peginterferon Alpha 2a
• Date of first enrolment: January 2013
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02368288
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: yao xie, MD

• Name: Yao Xie, doctor

Key inclusion & exclusion criteria

Inclusion Criteria:

- HBeAg positive patients with HBV DNA load =1000copies/ml after 6 months of
peginterferon a-2a treatment

Exclusion Criteria:

- Active consumption of alcohol and/or drugs

- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D
virus

- History of autoimmune hepatitis

- Psychiatric disease

- Evidence of neoplastic diseases of the liver



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Intervention(s)

Drug: entecavir

Primary Outcome(s)

rate of HBeAg seroconversion [Time Frame: 48 weeks]

Secondary Outcome(s)

rate of HBsAg loss [Time Frame: 48 weeks]

Secondary ID(s)

DTXY005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors