Chronic Hepatitis BPhase 43E ExNCT01834508
3E Extension Study
A Phase 4 study testing oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks in people with Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 28 sites in China.
Trial summary
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 28 sitesChina
- Study dates
- Mar 2013to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
- Subjects who are willing to participate the extension study.
Who cannot join
- Subjects who could not compliance with the protocol judged by investigators
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
302 Military Hospital Of China
Beijing, Beijing Municipality
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
No. 8 People's Hospital In GuangZhou
Guangzhou, Guangdong
The Third Hospital of Sun Yat-Sen University
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
No.81 Hospital of PLA
Nanjing, Jiangsu
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
Shengyang, 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 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.
- Conditions
- Chronic Hepatitis B
- Being tested
- oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
- Keywords
- Experienced Treatment
- 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.
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | Not described Receives: Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of patients achieving HBV DNA< 300copies/mL at week 144
Measured: Week 144
Secondary outcomes (4)
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
Measured: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
Measured: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Measured: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Measured: Week 48 & 96 & 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
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 12th Five-year
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834508
- Sponsor's protocol ID
- MOH-07
- Acronym
- 3E Ex
- Status last verified
- Jun 2014
- First submitted
- 14 Apr 2013
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study
- ClinicalTrials.gov ID
- NCT01834508
- Acronym / sponsor ID
- 3E Ex / MOH-07
- Conditions
- Chronic Hepatitis B
- Keywords
- Experienced Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Major Science and Technology Special Project of China 12th Five-year
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Apr 2013 (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 evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
- Subjects who are willing to participate the extension study.
Key exclusion criteria (1 listed)
- Subjects who could not compliance with the protocol judged by investigators
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 |
|---|---|---|
| oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks | Drug | Treatment group |
Primary outcome
Percentages of patients achieving HBV DNA< 300copies/mL at week 144
Time frame: Week 144
4 secondary outcomes
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
Time frame: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
Time frame: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time frame: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Time frame: Week 48 & 96 & 144
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
28 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 oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks in people with Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University at 28 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 2 inclusion and 1 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 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Results are not available in the source record.
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?
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 (time frame: Week 144). 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 19 Jun 2014; AzTrials last refreshed its copy on 29 Oct 2026.