Hepatitis B, ChronicPhase 4NCT02482272
Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
A Phase 4 study testing Lamivudine, Adefovir and Entecavir in people with Hepatitis B, Chronic, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Lamivudine, Adefovir and Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to May 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis B
- Age ≥ 20 year old
- Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
- Proven Lamivudine resistant mutation
- HBV DNA levels at screening ≥ 15 IU/mL
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
- Patient is able to give written informed consent prior to study start and to comply with the study requirements
Who cannot join
- A history or current of decompensated cirrhosis or hepatocellular carcinoma
- Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
- Co-infected with HCV or HIV
- A history of organ transplantation
- Pregnant or breast-feeding
- Current clinically relevant of abuse of alcohol or drugs.
- Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
- malignancy in previous 5 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Young Hwa Chung
About this study
Official title: Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir
- Conditions
- Hepatitis B, Chronic
- Being tested
- Lamivudine, Adefovir, Entecavir
- 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
Lamivudine 100mg/day orally
AdefovirDrug
Adefovir 10mg/day orally
EntecavirDrug
Entecavir 1mg/day orally
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine plus Adefovir or Adefovir | Active comparator | Lamivudine+Adefovir or Adefovir for 48 weeks Receives: Drug: Lamivudine; Drug: Adefovir |
| Entecavir plus Adefovir | Experimental | Entecavir+Adefovir for 48 weeks Receives: Drug: Adefovir; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBV DNA<15IU/mL
Measured: week 48
Secondary outcomes (8)
Proportion of patients with HBV DNA<15IU/mL
Measured: Day1, week12, week 24, week 36, week 48
The change of HBV DNA from the baseline
Measured: week 48
Proportion of patients with ALT normalization
Measured: Day1, week12, week 24, week 36, week 48
Proportion of patients with HBeAg loss and/or seroconversion
Measured: Day1, week12, week 24, week 36, week 48
The change of HBsAg from the baseline
Measured: week 48
Proportion of patients with HBsAg loss and/or seroconversion
Measured: week 24, week 48
Proportion of patients who experienced virologic breakthrough
Measured: week 48
Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)
Composite outcome measure consisting of multiple measures, including:
- Number of patients with Adverse events( including SAEs)
- Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time
- Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other
- Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Hwa Chung, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482272
- Sponsor's protocol ID
- ENTADE
- Status last verified
- Dec 2015
- First submitted
- 1 Jun 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy
- ClinicalTrials.gov ID
- NCT02482272
- Acronym / sponsor ID
- ENTADE
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 26 Jun 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.
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine plus Adefovir or Adefovir | Active comparator | Drug: Lamivudine, Drug: AdefovirLamivudine+Adefovir or Adefovir for 48 weeks |
| Entecavir plus Adefovir | Experimental | Drug: Adefovir, Drug: EntecavirEntecavir+Adefovir for 48 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic hepatitis B
- Age ≥ 20 year old
- Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
- Proven Lamivudine resistant mutation
- HBV DNA levels at screening ≥ 15 IU/mL
Key exclusion criteria (8 listed)
- A history or current of decompensated cirrhosis or hepatocellular carcinoma
- Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
- Co-infected with HCV or HIV
- A history of organ transplantation
- Pregnant or breast-feeding
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 |
|---|---|---|
| LamivudineLamivudine 100mg/day orally | Drug | Lamivudine plus Adefovir or Adefovir |
| AdefovirAdefovir 10mg/day orally | Drug | Entecavir plus Adefovir, Lamivudine plus Adefovir or Adefovir |
| EntecavirEntecavir 1mg/day orally | Drug | Entecavir plus Adefovir |
Primary outcome
Proportion of patients with HBV DNA<15IU/mL
Time frame: week 48
8 secondary outcomes
Proportion of patients with HBV DNA<15IU/mL
Time frame: Day1, week12, week 24, week 36, week 48
The change of HBV DNA from the baseline
Time frame: week 48
Proportion of patients with ALT normalization
Time frame: Day1, week12, week 24, week 36, week 48
Proportion of patients with HBeAg loss and/or seroconversion
Time frame: Day1, week12, week 24, week 36, week 48
The change of HBsAg from the baseline
Time frame: week 48
Proportion of patients with HBsAg loss and/or seroconversion
Time frame: week 24, week 48
Proportion of patients who experienced virologic breakthrough
Time frame: week 48
Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)
Time frame: week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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?
A Phase 4 study testing Lamivudine, Adefovir and Entecavir in people with Hepatitis B, Chronic, run by Asan Medical Center at 1 site in South Korea.
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 7 inclusion and 8 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 30 Dec 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 South Korea. 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 Danbi Lee (82)2-3010-3907, leighdb@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HBV DNA<15IU/mL (time frame: week 48). 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 30 Dec 2015.