Hepatitis B, ChronicPhase 4EFFORT-ExNCT01529255
EFFORT Extension Study
A Phase 4 study testing telbivudine (ROADMAP) in people with Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 24 sites in China.
Trial summary
The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- telbivudine (ROADMAP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 24 sitesChina
- Study dates
- Aug 2011to Dec 2015
- 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
- Treated with telbivudine or combined with adefovir in EFFORT study
- Patients are willing to participate in the extension study
- Patients provide information consent form
Who cannot join
- Adjustment of poor compliance by investigators
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 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
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong
No. 8 People's Hospital In GuangZhou
Guangzhou, Guangdong
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang
JiNan Infectious Diseases Hospital
Jinan, Shandong
No.81 Hospital of PLA
Nanjing, Jiangsu
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-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
- The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
- To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment
- Conditions
- Hepatitis B, Chronic
- Being tested
- telbivudine (ROADMAP), Telbivudine (Standard of Care)
- Keywords
- Chronic Hepatitis B, Compensated 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.
telbivudine (ROADMAP)Drug
Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
Stopping rules:
The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.
The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.
Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.
Telbivudine (Standard of Care)Drug
Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
Stopping rules:
The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.
The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.
Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.
| Study group | Role | What they receive |
|---|---|---|
| ROADMAP | Experimental | Not described Receives: Drug: telbivudine (ROADMAP) |
| SOC (Standard of Care) | Active comparator | Not described Receives: Drug: Telbivudine (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
Measured: Week 48
Secondary outcomes (9)
Percentage of patients achieving HBV DNA <300copies/mL at week 156
Measured: Week 156
The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
Measured: Week 156
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
Measured: Week 156
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
Measured: Week 156
The percentage of patients with ALT normalization at week 156
Measured: Week 156
Percentage of patients with HBV DNA breakthrough at week 156
Measured: Week 156
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156
Measured: Week 156
sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration
Measured: week 52 of off-treatment
percentage of hepatitis flare at week 52 of off-treatment duration
Measured: week 52 of off-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (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 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
- 576 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 Eleventh Five-year, Novartis
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529255
- Sponsor's protocol ID
- MOH-05
- Acronym
- EFFORT-Ex
- Status last verified
- Jun 2014
- First submitted
- 20 Sep 2011
- 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-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
- ClinicalTrials.gov ID
- NCT01529255
- Acronym / sponsor ID
- EFFORT-Ex / MOH-05
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic Hepatitis B, Compensated Chronic hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Major Science and Technology Special Project of China Eleventh Five-year, Novartis
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Feb 2012 (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 to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
- To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROADMAP | Experimental | Drug: telbivudine (ROADMAP) |
| SOC (Standard of Care) | Active comparator | Drug: Telbivudine (Standard of Care) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treated with telbivudine or combined with adefovir in EFFORT study
- Patients are willing to participate in the extension study
- Patients provide information consent form
Key exclusion criteria (1 listed)
- Adjustment of poor compliance 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 |
|---|---|---|
| telbivudine (ROADMAP)Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial. | Drug | ROADMAP |
| Telbivudine (Standard of Care)Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial. | Drug | SOC (Standard of Care) |
Primary outcome
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
Time frame: Week 48
9 secondary outcomes
Percentage of patients achieving HBV DNA <300copies/mL at week 156
Time frame: Week 156
The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
Time frame: Week 156
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
Time frame: Week 156
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
Time frame: Week 156
The percentage of patients with ALT normalization at week 156
Time frame: Week 156
Percentage of patients with HBV DNA breakthrough at week 156
Time frame: Week 156
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156
Time frame: Week 156
sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration
Time frame: week 52 of off-treatment
percentage of hepatitis flare at week 52 of off-treatment duration
Time frame: week 52 of off-treatment
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.
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 telbivudine (ROADMAP) in people with Hepatitis B, Chronic, 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 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 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?
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?
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II (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 19 Jun 2014.