Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy

NCT02582333 | Completed

• 1 other identifier: CF15240B
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 4

Brief Summary

Background: Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future. Objectives:

1. 1.To access the clinical and virological changes after stopping NA therapy
2. 2.To determine important prognostic indicators for stopping NA therapy
3. 3.Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
4. 4.Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.

Conditions

Virological Breakthrough; Prognosis

Outcome Measures

Primary Outcomes (1)

• HBsAg seroconversion

  HBsAg negative, anti-HBs positive

  2 years after stopping nucleos(t)ide analogue

Study Arms (2)

Tenofovir

Chronic hepatitis B patients who receive tenofovir as their first anti-HBV therapy and are indicated for stopping tenofovir therapy

Other: Observation for clinical and virological changes

Entecavir

Chronic hepatitis B patients who receive entecavir as their first anti-HBV therapy and are indicated for stopping entecavir therapy

Other: Observation for clinical and virological changes

Interventions

Observation for clinical and virological changes OTHER

Only observation after stopping nucleos(t)ide analogue

Entecavir; Tenofovir

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis B patients who are indicated for stopping nucleos(t)ide analogue therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study

You may qualify if:

• Age \> or = 20 years old
• Chronic hepatitis B patients who received tenofovir or entecavir as their first anti-HBV therapy
• Patients who have received nucleos(t)ide analogue therapy for \> 3 years or reached the stopping criteria of APASL ( HBeAg+ patients: HBeAg seroconversion \> 12 months; HBeAg - patients: HBV DNA undetectable \> 12 months)

You may not qualify if:

• History of liver cirrhosis or hepatocellular carcinoma
• Recipients of liver transplantation
• Concurrent malignancies (except curable skin cancers)
• Concomitant use of immunosuppressants
• Coinfection with HCV, HDV, HIV

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (4)

Show Chwan Memorial Hospital

Changhua, Taiwan

Location

Cheng Ching General Hospital-Chung Kang Branch

Taichung, 40705, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40705, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

HBV DNA and genotype

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Teng-Yu Lee, MD, PhD

  Taichung Veterans General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology & Hepatology Division

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: March 13, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

TW (4)