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Trial record 91 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Teng-Yu Lee, Taichung Veterans General Hospital
Sponsor:
Information provided by (Responsible Party):
Teng-Yu Lee, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT02582333
First received: October 20, 2015
Last updated: April 20, 2016
Last verified: April 2016
  Purpose

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. To access the clinical and virological changes after stopping NA therapy
  2. To determine important prognostic indicators for stopping NA therapy

Methods:

In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:

  1. Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
  2. 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.

Condition Intervention
Virological Breakthrough Prognosis Other: Observation for clinical and virological changes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy

Resource links provided by NLM:


Further study details as provided by Teng-Yu Lee, Taichung Veterans General Hospital:

Primary Outcome Measures:
  • HBsAg seroconversion [ Time Frame: 2 years after stopping nucleos(t)ide analogue ]

Biospecimen Retention:   Samples With DNA
HBV DNA and genotype

Estimated Enrollment: 400
Study Start Date: October 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Only observation after stopping nucleos(t)ide analogue
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
Only observation after stopping nucleos(t)ide analogue

Detailed Description:

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. To access the clinical and virological changes after stopping NA therapy
  2. To determine important prognostic indicators for stopping NA therapy

Methods:

In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:

  1. Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
  2. 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.

Importance:

To clinicians in treating chronic hepatitis B, this study will provide important data regarding the clinical courses after stopping NA therapy, and important prognostic indicators may be determined. These findings could help clinicians in decision making for discontinuation of NA therapy and booking follow-up schedules. To basic scientists, this study will provide the virological changes after stopping NA therapy, and these findings may help developing further virological researches.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. Age > or = 20 years old
  2. Chronic hepatitis B patients who received tenofovir or entecavir as their first anti-HBV therapy
  3. 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)

Exclusion Criteria:

  1. History of liver cirrhosis or hepatocellular carcinoma
  2. Recipients of liver transplantation
  3. Concurrent malignancies (except curable skin cancers)
  4. Concomitant use of immunosuppressants
  5. Coinfection with HCV, HDV, HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02582333

Contacts
Contact: Teng-Yu Lee, MD, PhD +886423592525 ext 3301 tylee@vghtc.gov.tw

Locations
Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua, Taiwan
Contact: Jee-Chun Yang, MD    886-4-7256166    a0937434696@gmail.com   
Sub-Investigator: Chih-Sheng Wu, MD         
Cheng Ching General Hospital-Chung Kang Branch Recruiting
Taichung, Taiwan, 40705
Contact: Jen-Chieh Huang, MD    +886423592525    shdenchen@yahoo.com.tw   
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Chun-Che Lin, MD, PhD    +886424738585 ext 32346    cshy333@csh.org.tw   
Sub-Investigator: Ming- Chang Tsai, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Teng-Yu Lee, MD, PhD    +886423592525 ext 3301    tylee@vghtc.gov.tw   
Principal Investigator: Sheng-Shun Yang, MD, PhD         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Study Chair: Teng-Yu Lee, MD, PhD Taichung Veterans General Hospital
  More Information

Responsible Party: Teng-Yu Lee, Gastroenterology & Hepatology Division, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02582333     History of Changes
Other Study ID Numbers: CF15240B
Study First Received: October 20, 2015
Last Updated: April 20, 2016

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 16, 2017