Hepatitis B, ChronicPhase 4EFFORTNCT00962533
EFFicacy Optimization Research of Telbivudine Therapy
A Phase 4 study testing telbivudine in people with Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 24 sites in China.
Trial summary
The purpose of this trial is to prove that the 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 24 sitesChina
- Study dates
- Aug 2009to Aug 2012
- 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, from 18 (inclusive) to 65 (inclusive) years of age
- HBsAg and HBeAg positive for over six months
- Patient is willing and able to comply with the study drug regimen and all other study requirements
- Patients must give written informed consent before any assessment is performed
Who cannot join
- Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
- Patient has a history of or clinical signs/symptoms of hepatic decompensation
- Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- Other protocol-defined inclusion/exclusion criteria may apply
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
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 Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)
The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
- Conditions
- Hepatitis B, Chronic
- Being tested
- telbivudine
- 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.
telbivudineDrug
Also called Sebivo®
telbivudine, 600mg, oral, daily
telbivudineDrug
Also called Sebivo®
telbivudine, 600mg, oral, daily
| Study group | Role | What they receive |
|---|---|---|
| ROADMAP Group (Group I) | Experimental | Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load:
* Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28;
* Group I-B: This group of patients was those with HBV DNA <300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added;
The total treatment duration was 104 weeks. Receives: Drug: telbivudine |
| SOC (Standard of Care) Group (Group II) | Active comparator | patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added. Receives: Drug: telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
Measured: Week 104
Secondary outcomes (5)
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
Measured: week 52
Serum HBV DNA reduction from baseline at week 104
Measured: week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
Measured: week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
Measured: week 104
Serum HBV DNA reduction from baseline at week 52
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 606 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, Novartis
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962533
- Sponsor's protocol ID
- MOH-01
- Acronym
- EFFORT
- Status last verified
- Mar 2012
- First submitted
- 18 Aug 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13.
PubMed 17632041Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1.
PubMed 32189364
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)
- ClinicalTrials.gov ID
- NCT00962533
- Acronym / sponsor ID
- EFFORT / MOH-01
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- 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 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Aug 2009 (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 trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROADMAP Group (Group I) | Experimental | Drug: telbivudinePatients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load: * Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28; * Group I-B: This group of patients was those with HBV DNA <300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added; The total treatment duration was 104 weeks. |
| SOC (Standard of Care) Group (Group II) | Active comparator | Drug: telbivudinepatients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, from 18 (inclusive) to 65 (inclusive) years of age
- HBsAg and HBeAg positive for over six months
- Patient is willing and able to comply with the study drug regimen and all other study requirements
- Patients must give written informed consent before any assessment is performed
Key exclusion criteria (4 listed)
- Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
- Patient has a history of or clinical signs/symptoms of hepatic decompensation
- Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| telbivudineAlso: Sebivo®telbivudine, 600mg, oral, daily | Drug | ROADMAP Group (Group I) |
| telbivudineAlso: Sebivo®telbivudine, 600mg, oral, daily | Drug | SOC (Standard of Care) Group (Group II) |
Primary outcome
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
Time frame: Week 104
5 secondary outcomes
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
Time frame: week 52
Serum HBV DNA reduction from baseline at week 104
Time frame: week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
Time frame: week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
Time frame: week 104
Serum HBV DNA reduction from baseline at week 52
Time frame: week 52
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 31 Jan 2013.
- Background: PubMed 17632041Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13.
- Derived from this study: PubMed 32189364Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1.
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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 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 4 inclusion and 4 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 31 Jan 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?
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II (time frame: Week 104). 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 NCT00962533, which also lists 2 linked publications.
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 31 Jan 2013.