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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03366571
• Other study ID #: D161100002716003
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2024

Study information

• Verified date: April 2021
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.

• Patients comply with the requirements of the trail voluntarily

• Written informed consent

Exclusion Criteria:

• Pregnant woman or patient with severe disease

• Patients with poor adherence to the study

• Patients not suitable for the study evaluated by the investigator

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing YouAn Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hopsital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Ditan Hospital, Beijing YouAn Hospital, Peking University First Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death	Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage),and/or hepatocellular carcinoma, and/or liver related death after 10 years of antiviral treatment	10 years
Secondary	HBV-DNA undetectable rate	HBV-DNA undetectable rate after 10 years of antiviral treatment	10 years
Secondary	Decrease of transient elastography	Decrease of transient elastography after 10 years of antiviral treatment	10 years
Secondary	HBeAg seroconversion rate	HBeAg seroconversion rate after 10 years of antiviral treatment	10 years
Secondary	HBsAg seroconversion rate	HBsAg seroconversion rate after 10 years of antiviral treatment	10 years
Secondary	Decrease of Child-Pugh score	Decrease of Child-Pugh score after 10 years of antiviral treatment	10 years
Secondary	Decrease of MELD score	Decrease of MELD score after 10 years of antiviral treatment	10 years
Secondary	Improvement of life Quality assessed by SF-36	Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment	10 years
Secondary	Improvement of life Quality assessed by EQ-5D	Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment	10 years