Compensated Chronic Hepatitis BPhase 4EXPLORENCT01088009
Efficacy Optimizing Research of Lamivudine Therapy
A Phase 4 study testing lamivudine and lamivudine, adefovir in people with Compensated Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 24 sites in China.
Trial summary
The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Compensated Chronic Hepatitis B
- What is being tested?
- lamivudine and lamivudine, adefovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 24 sitesChina
- Study dates
- Mar 2010to May 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years;
- Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;
Who cannot join
- History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- other protocol defined inclusion/exclusion criteria
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Beijing Ditan Hospita
Beijing, Beijing Municipality
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality
BeiJing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality
People'S Hospital Under Beijnig University
Beijing, Beijing Municipality
First Hospital .Jilin Unniversity
Changchun, Jilin
Xiangya Hospital Central-South Univrsity
Changsha, Hunan
West China Hospital.SiChuan University
Chengdu, Sichuan
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing Municipality
The First People's Hospital of Foshan
Foshan, Guangdong
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Department of infectious disease, Nanfang Hospital
Guangzhou, Guangdong
GuangDong Provincial People's hospital
Guangzhou, Guangdong
HangZhou No.6 People Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of College of Medicine ，Zhejiang University
Hangzhou, Zhejiang
JiNan Infectious Diseases Hospital
Jinan, Shandong
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality
No.85 Hospital of PLA
Shanghai, Shanghai Municipality
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
ShengJing Hospital of China Medical University
Shenyang, Liaoning
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Tangdu Hospital
XiAn, Shanxi
About this study
Official title: A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients
The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.
- Conditions
- Compensated Chronic Hepatitis B
- Being tested
- lamivudine, lamivudine, adefovir
- Keywords
- chronic hepatitis B
- 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
patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104
lamivudineDrug
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
lamivudine, adefovirDrug
patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| early add-on | Experimental | Not described Receives: Drug: lamivudine |
| SOC | Active comparator | Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Receives: Drug: lamivudine |
| De-novo combination | Other | patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks Receives: Drug: lamivudine, adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants
Measured: during 104 weeks study period
Secondary outcomes (5)
proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
Measured: week 104
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
Measured: baseline, week 104
The proportion of subjects with ALT normalization at week 104
Measured: week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104
Measured: week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104
Measured: week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compensated Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Major Science and Technology Special Project of China Eleventh Five-year, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- JinLin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088009
- Sponsor's protocol ID
- MOH-02
- Acronym
- EXPLORE
- Status last verified
- Sep 2013
- First submitted
- 15 Mar 2010
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiang KH, Michailidis E, Ding H, Peng YQ, Su MZ, Li Y, Liu XE, Dao Thi VL, Wu XF, Schneider WM, Rice CM, Zhuang H, Li T. Effects of amino acid substitutions in hepatitis B virus surface protein on virion secretion, antigenicity, HBsAg and viral DNA. J Hepatol. 2017 Feb;66(2):288-296. doi: 10.1016/j.jhep.2016.09.005. Epub 2016 Sep 17.
PubMed 27650283
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients
- ClinicalTrials.gov ID
- NCT01088009
- Acronym / sponsor ID
- EXPLORE / MOH-02
- Conditions
- Compensated Chronic Hepatitis B
- Keywords
- chronic hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Major Science and Technology Special Project of China Eleventh Five-year, GlaxoSmithKline
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Mar 2010 (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 the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early add-on | Experimental | Drug: lamivudine |
| SOC | Active comparator | Drug: lamivudinePatients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily |
| De-novo combination | Other | Drug: lamivudine, adefovirpatients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18-65 years;
- Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;
Key exclusion criteria (2 listed)
- History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- other protocol defined inclusion/exclusion criteria
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 |
|---|---|---|
| lamivudinepatients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104 | Drug | early add-on |
| lamivudinePatients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily | Drug | SOC |
| lamivudine, adefovirpatients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks | Drug | De-novo combination |
Primary outcome
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants
Time frame: during 104 weeks study period
5 secondary outcomes
proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
Time frame: week 104
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
Time frame: baseline, week 104
The proportion of subjects with ALT normalization at week 104
Time frame: week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104
Time frame: week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104
Time frame: week 104
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Derived from this study: PubMed 27650283Xiang KH, Michailidis E, Ding H, Peng YQ, Su MZ, Li Y, Liu XE, Dao Thi VL, Wu XF, Schneider WM, Rice CM, Zhuang H, Li T. Effects of amino acid substitutions in hepatitis B virus surface protein on virion secretion, antigenicity, HBsAg and viral DNA. J Hepatol. 2017 Feb;66(2):288-296. doi: 10.1016/j.jhep.2016.09.005. Epub 2016 Sep 17.
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.
JinLin Hou, MD principal investigator
Nanfang Hospital, Southern Medical University
24 sites 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 and lamivudine, adefovir in people with Compensated Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 24 sites in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants (time frame: during 104 weeks study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088009, which also lists 1 linked publication.
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 Oct 2013.