Chronic Hepatitis bNCT03042481
Off-therapy Response After Stopping Entecavir or Tenofovir
An observational study of Chronic Hepatitis b, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis b
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping nucleot(s)ide therapy.
Who may be able to join
- Male and female patients >20 years of age
- Positive HBsAg for more than 6 months prior to ETV or TDF therapy.
- 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.
- 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.
Who cannot join
- Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) co-infection.
- 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)
- Evidence of drug abuse (including excessive alcohol consumption).
- Prophylactic use of ETV or TDF therapy. (for cancer chemotherapy or post-transplant immunosuppressive therapy prophylaxis)
- Patients who have clinical evidence of liver cirrhosis.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Hepatobiliary, Kaohsiung Medical University Hospital
Kaohsiung City
Jee-Fu Huang, Director, +886 73121101 ext. 7475, jf71218@gmail.com
About this study
Official title: 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
Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of having a potent antiviral effect, and good tolerance without side effect. The long-term safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients treated with lamivudine. A recent study investigating the post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been identified, there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently. Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy response are also still uncertain.
The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy, and to identify the predictive factors of relapse.
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, entecavir, tenofovir, off-therapy, relapse
- Medical subject headings
- Hepatitis B, Chronic, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HBV relapse
Measured: One year after stopping HBV antiviral therapy
Rate of HBV relapse
Measured: Two year after stopping HBV antiviral therapy
Secondary outcomes (2)
Rate of severe hepatitis flare (ALT level ≥10 fold the ULN) with/without hepatic decompensation (total bilirubin ≥2).
Measured: One year after stopping NUCs
Rate of severe hepatitis flare (ALT level ≥10 fold the ULN) with/without hepatic decompensation (total bilirubin ≥2).
Measured: Two year after stopping HBV antiviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042481
- Sponsor's protocol ID
- KMUHIRB-G(I)-20160015
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03042481
- Acronym / sponsor ID
- KMUHIRB-G(I)-20160015
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, entecavir, tenofovir, off-therapy, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of having a potent antiviral effect, and good tolerance without side effect. The long-term safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients treated with lamivudine. A recent study investigating the post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been identified, there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently. Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy response are also still uncertain.
The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy, and to identify the predictive factors of relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping nucleot(s)ide therapy.
Key inclusion criteria (4 listed)
- Male and female patients >20 years of age
- Positive HBsAg for more than 6 months prior to ETV or TDF therapy.
- 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.
- 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.
Key exclusion criteria (6 listed)
- Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) co-infection.
- 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)
- Evidence of drug abuse (including excessive alcohol consumption).
- Prophylactic use of ETV or TDF therapy. (for cancer chemotherapy or post-transplant immunosuppressive therapy prophylaxis)
- Patients who have clinical evidence of liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of HBV relapse
Time frame: One year after stopping HBV antiviral therapy
Rate of HBV relapse
Time frame: Two year after stopping HBV antiviral therapy
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MING-LUN YEH, MD (+886 73121101 ext. 7475, minglunyeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HBV relapse (time frame: One year after stopping HBV antiviral therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.