NCT03366571

Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Detailed description

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Nucleos(t)ide Analogues	Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2017-12-08
• Last updated: 2021-04-14

Locations

4 sites across 1 country: China