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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03042481 |
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Date of registration:
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23/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Off-therapy Response After Stopping Entecavir or Tenofovir
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Scientific title:
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Comparison and Prediction of Off-therapy Response in Patients of Chronic Hepatitis B Treated With Entecavir or Tenofovir and Achieved Criteria of Stopping Therapy by APASL Guideline |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03042481 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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MING-LUN YEH, MD |
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Address:
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Telephone:
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+886 73121101 |
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Email:
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minglunyeh@gmail.com |
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Affiliation:
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Name:
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Jee-Fu Huang, Director |
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Address:
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Telephone:
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+886 73121101 |
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Email:
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jf71218@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male and female patients >20 years of age
2. Positive HBsAg for more than 6 months prior to ETV or TDF therapy.
3. HBV DNA =20,000 IU/mL and alanine aminotransferase (ALT) levels = 2 fold the upper
limit of normal (ULN) for the HBeAg-positive patients, and HBV DNA =2000 IU/mL and ALT
levels = 2 fold the ULN for the HBeAg-negative patients prior to ETV or TDF therapy.
4. Achieve the APASL criteria of stopping NUC therapy including HBeAg seroconversion
(negative HBeAg and positive HBeAb) with HBV DNA loss measured at two consecutive
occasions at least 6 months apart for HBeAg positive patients; more than 2 years
therapy with undetectable HBV DNA documented on three separate occasions 6 months
apart for HBeAg negative patients.
Exclusion Criteria:
1. Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) co-infection.
2. History or other evidence of a medical condition associated with chronic liver disease
other than CHB (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease,
alcoholic liver disease, toxin exposures)
3. Evidence of drug abuse (including excessive alcohol consumption).
4. Prophylactic use of ETV or TDF therapy. (for cancer chemotherapy or post-transplant
immunosuppressive therapy prophylaxis)
5. Patients who have clinical evidence of liver cirrhosis.
6. Inability or unwillingness to provide informed consent or abide by the requirements of
the study.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis b
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Primary Outcome(s)
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Rate of HBV relapse
[Time Frame: Two year after stopping HBV antiviral therapy]
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Rate of HBV relapse
[Time Frame: One year after stopping HBV antiviral therapy]
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Secondary Outcome(s)
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Rate of severe hepatitis flare (ALT level =10 fold the ULN) with/without hepatic decompensation (total bilirubin =2).
[Time Frame: One year after stopping NUCs]
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Rate of severe hepatitis flare (ALT level =10 fold the ULN) with/without hepatic decompensation (total bilirubin =2).
[Time Frame: Two year after stopping HBV antiviral therapy]
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Secondary ID(s)
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KMUHIRB-G(I)-20160015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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