Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients

NCT02387684 | Unknown

• 1 other identifier: DTXY007
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B; interferon; peginterferon; HBsAg loss

Outcome Measures

Primary Outcomes (1)

• rate of sustained viral response

  Sutained viral response was defined as serum HBV DNA undetectable at the end of treatment and the end of 24 weeks follow up.

  120 weeks

Secondary Outcomes (1)

• rate of HBsAg loss

  96 weeks

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population in this cohort study was composed of HBeAg negative chronic hepatitis B patients defined as HBsAg positive, HBeAg negative,and detectable HBV DNA load with ALT level ≥41 U/L for more than 6 months.

You may qualify if:

• HBeAg negative chronic hepatitis B patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yao xie, MD

CONTACT

8610-84322489; xieyao00120184@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: liver diseases center

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 13, 2015
• Study Start: April 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

CN (1)