Hepatitis B, ChronicPhase 4STENNCT01521975
A Two-year Study of Telbivudine in HBeAg Negative Hepatitis
A Phase 4 study testing Telbivudine, Adefovir dipivoxil in people with Hepatitis B, Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time… 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, Adefovir dipivoxil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 30 May 2014
- 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
- Detectable serum HBsAg at the Screening visit and at least 6 months prior
- HBeAg negative at Screening visit
- serum HBV DNA level >2,000 IU/mL at Screening visit
- Elevated serum ALT≥2 ×ULN and <10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)
Who cannot join
- Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
- Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)>50ng/mL.
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
- Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
- Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
- Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
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- Patient has used hepatotoxic drugs within one month.
- Patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
- Use of other investigational drugs at the time of enrollment.
- History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
- Patient is co-infected with HCV, HDV or HIV.
- Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
- History of malignancy of any organ system.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: A Two-year, Open-label, Virological Response Adaptive Design, Multicenter Study to Evaluate Efficacy of Telbivudine in HBeAg Negative Adult CHB Patients With Roadmap Strategy
Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.
Read the detailed description
This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they will be divided into 2 Groups according to virological response. Patients with PCR detectable HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Telbivudine, Adefovir dipivoxil
- Keywords
- HBV DNA, LdT, ADV, HBeAg negative hepatitis, CHB
- 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, Adefovir dipivoxilDrug
Also called Sebivo, LDT
All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.
| Study group | Role | What they receive |
|---|---|---|
| HBeAg Negative Hepatitis | Experimental | HBeAg Negative Hepatitis patients. Receives: Drug: Telbivudine, Adefovir dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with undectable HBV DNA
Measured: at Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start1 Jan 2011
- Primary completion28 Feb 2014
- Study completion30 May 2014
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 Hepatitis B, ChronicStudies 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Guangzhou 8th People's Hospital
- Responsible party
- Principal investigator, Chao-Shuang Lin, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhi-Liang Gao, Prof, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521975
- Sponsor's protocol ID
- HBeAg negative Roadmap
- Acronym
- STEN
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2012
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gan W, Li J, Zhang C, Chen X, Lin C, Gao Z. Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections. BMC Infect Dis. 2020 Dec 7;20(1):931. doi: 10.1186/s12879-020-05642-y.
PubMed 33287722
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-year, Open-label, Virological Response Adaptive Design, Multicenter Study to Evaluate Efficacy of Telbivudine in HBeAg Negative Adult CHB Patients With Roadmap Strategy
- ClinicalTrials.gov ID
- NCT01521975
- Acronym / sponsor ID
- STEN / HBeAg negative Roadmap
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBV DNA, LdT, ADV, HBeAg negative hepatitis, CHB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Guangzhou 8th People's Hospital
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 28 Feb 2014 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 31 Jan 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.
Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.
Detailed description
This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they will be divided into 2 Groups according to virological response. Patients with PCR detectable HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBeAg Negative Hepatitis | Experimental | Drug: Telbivudine, Adefovir dipivoxilHBeAg Negative Hepatitis patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Detectable serum HBsAg at the Screening visit and at least 6 months prior
- HBeAg negative at Screening visit
- serum HBV DNA level >2,000 IU/mL at Screening visit
- Elevated serum ALT≥2 ×ULN and <10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)
Key exclusion criteria (14 listed)
- Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
- Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)>50ng/mL.
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
- Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
- Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
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, Adefovir dipivoxilAlso: Sebivo, LDTAll patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil. | Drug | HBeAg Negative Hepatitis |
Primary outcome
The percentage of patients with undectable HBV DNA
Time frame: at 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 24 Oct 2017.
- Derived from this study: PubMed 33287722Gan W, Li J, Zhang C, Chen X, Lin C, Gao Z. Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections. BMC Infect Dis. 2020 Dec 7;20(1):931. doi: 10.1186/s12879-020-05642-y.
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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.
Zhi-Liang Gao, Prof principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
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 Telbivudine, Adefovir dipivoxil in people with Hepatitis B, Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site 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 14 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 24 Oct 2017. 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 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 percentage of patients with undectable HBV DNA (time frame: at 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 NCT01521975, 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 24 Oct 2017.