Chronic Hepatitis BPhase 4NCT02337127
Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents
A Phase 4 study testing Lamivudine in people with Chronic Hepatitis B, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to May 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients >=18 years of age
- Negative serum HBV DNA within 3 months prior to entry
- ALT <1.5 ULN within 3 months prior to entry
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females of the Lamivudine treatment arm must be using reliable contraception during the study and for 6 months after treatment completion.
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
- Any investigational drug *6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis C and/or human immunodeficiency virus (HIV)
- Patients who have virological evidence of Lamivudine-associated YMDD mutants.
- Patients who have clinical evidence of liver cirrhosis or hepatocellular carcinoma.
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- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Signs or symptoms of hepatocellular carcinoma
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
- Serum creatinine level >1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Trial locations and contacts
1 site in 1 country.
Wan-Long Chuang contact
Taiwan1 site, 1 recruiting
- Recruiting
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital
Kaohsiung City, NRW
Wan-Long Chuang
About this study
Official title: A Prospective, Open-label, Multicenter Study of Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents
Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.
Read the detailed description
The purposes of this study are:
- To evaluate the long-term efficacy of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
- To evaluate the long-term outcomes and predictive factors of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
A prospective, open-label, multicenter study will enroll 500 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents. With their voluntary decision after consultation, 250 patients will receive Lamivudine extending therapy for 5 years and the other 250 patients will receive follow-up and serve as controls. The primary outcome measurement is HBV DNA recurrence, whilst the secondary outcome measurement is liver-related outcomes and associated predictive factors
- Conditions
- Chronic Hepatitis B
- Being tested
- Lamivudine
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
Also called Zeffix
Lamivudine, 100mg/day, per os
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive Lamivudine extending therapy for 5 years. Receives: Drug: Lamivudine |
| Arm B | No intervention | 250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HBV DNA recurrence
Measured: up to 12 months
Secondary outcomes (3)
Associated predictive factors of HBV DNA recurrence
Measured: up to 12 months
Rate of drug resistant mutation
Measured: up to 12 months
Rate of clinical relapse in Group B (non-intervention)
clinical relapse means HBV DNA>2000 IU/mL plus ALT > 2 fold upper limit of normal (ULN) in end of entecavir (ETV) normal alanine aminotransferase (ALT) or 2 fold elevation in end of ETV abnormal ALT patients
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJun 2011
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Long Chuang, Principal investigator, Kaohsiung Medical University Hospital, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337127
- Sponsor's protocol ID
- KMUH-IRB-20110187
- Status last verified
- Jan 2015
- First submitted
- 1 Dec 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter Study of Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents
- ClinicalTrials.gov ID
- NCT02337127
- Acronym / sponsor ID
- KMUH-IRB-20110187
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Jan 2015 (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.
Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.
Detailed description
The purposes of this study are:
- To evaluate the long-term efficacy of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
- To evaluate the long-term outcomes and predictive factors of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents.
A prospective, open-label, multicenter study will enroll 500 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents. With their voluntary decision after consultation, 250 patients will receive Lamivudine extending therapy for 5 years and the other 250 patients will receive follow-up and serve as controls. The primary outcome measurement is HBV DNA recurrence, whilst the secondary outcome measurement is liver-related outcomes and associated predictive factors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Lamivudine250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive Lamivudine extending therapy for 5 years. |
| Arm B | No intervention | –250 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents will receive follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients >=18 years of age
- Negative serum HBV DNA within 3 months prior to entry
- ALT <1.5 ULN within 3 months prior to entry
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females of the Lamivudine treatment arm must be using reliable contraception during the study and for 6 months after treatment completion.
Key exclusion criteria (16 listed)
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
- Any investigational drug *6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis C and/or human immunodeficiency virus (HIV)
- Patients who have virological evidence of Lamivudine-associated YMDD mutants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LamivudineAlso: ZeffixLamivudine, 100mg/day, per os | Drug | Arm A |
Primary outcome
Rate of HBV DNA recurrence
Time frame: up to 12 months
3 secondary outcomes
Associated predictive factors of HBV DNA recurrence
Time frame: up to 12 months
Rate of drug resistant mutation
Time frame: up to 12 months
Rate of clinical relapse in Group B (non-intervention)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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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.
Wan-Long Chuang contact
Wan-Long Chuang principal investigator
Kaohsiung Medical University Hospital, Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine in people with 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 16 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 13 Jan 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wan-Long Chuang (waloch@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HBV DNA recurrence (time frame: up to 12 months). 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 13 Jan 2015.