Chronic Hepatitis BNCT01958229
Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
An observational study of Chronic Hepatitis B and Roadmap Concept in Chronic Hepatitis B Treatment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B, Roadmap Concept in Chronic Hepatitis B Treatment, 24-week PCR Negativity of Telbivudine
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Apr 2013
- Phase
- Observational
- 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
Study population: Chronic hepatitis B patients without cirrhosis
Who may be able to join
- Male or female 18 to 65 years of age
- Documented chronic hepatitis B defined by ALL of following:
- Clinical history compatible with compensated chronic hepatitis B
- Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit.
Who cannot join
- Pregnant or nursing
- co-infection with hepatitis C virus (HCV) or HIV
- Clinical or imaging diagnosis of cirrhosis
- Evidence of decreased renal function of creatinine >(=)2x ULN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection
This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.
Read the detailed description
This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.
Study purpose:
This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.
Objectives:
Primary:
To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.
Secondary:
- To observe the treatment outcomes.
- To validate the result of super-responder trial.
- To validate the Roadmap Concept.
Population:
The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.
- Conditions
- Chronic Hepatitis B, Roadmap Concept in Chronic Hepatitis B Treatment, 24-week PCR Negativity of Telbivudine, PCR Negativity at 52 and 104 Week, HBeAg Seroconversion Rate at 52 and 104 Week
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CHB patients without cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR negativity
Measured: week 52
HBeAg seroconversion rate
Measured: week 52
PCR negativity
Measured: week 104
HBeAg seroconversion rate
Measured: week 104
Secondary outcomes (4)
Rate of ALT normalization
Measured: week 52
Genotypic resistance
Measured: week 52
Rate of ALT normalization
Measured: week 104
Genotypic resistance
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 posted9 Oct 2013 (estimated)
- Study startDec 2009
- Primary completionMar 2012
- Study completionApr 2013
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.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia-Horng Kao, Professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958229
- Sponsor's protocol ID
- 200910027M
- Status last verified
- Oct 2013
- First submitted
- 1 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection
- ClinicalTrials.gov ID
- NCT01958229
- Acronym / sponsor ID
- 200910027M
- Conditions
- Chronic Hepatitis B, Roadmap Concept in Chronic Hepatitis B Treatment, 24-week PCR Negativity of Telbivudine, PCR Negativity at 52 and 104 Week, HBeAg Seroconversion Rate at 52 and 104 Week
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Oct 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.
This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.
Detailed description
This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.
Study purpose:
This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.
Objectives:
Primary:
To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.
Secondary:
- To observe the treatment outcomes.
- To validate the result of super-responder trial.
- To validate the Roadmap Concept.
Population:
The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHB patients without cirrhosis | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients without cirrhosis
Key inclusion criteria (4 listed)
- Male or female 18 to 65 years of age
- Documented chronic hepatitis B defined by ALL of following:
Key exclusion criteria (4 listed)
- Pregnant or nursing
- co-infection with hepatitis C virus (HCV) or HIV
- Clinical or imaging diagnosis of cirrhosis
- Evidence of decreased renal function of creatinine >(=)2x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PCR negativity
Time frame: week 52
HBeAg seroconversion rate
Time frame: week 52
PCR negativity
Time frame: week 104
HBeAg seroconversion rate
Time frame: week 104
4 secondary outcomes
Rate of ALT normalization
Time frame: week 52
Genotypic resistance
Time frame: week 52
Rate of ALT normalization
Time frame: week 104
Genotypic resistance
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 9 Oct 2013.
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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.
Jia-Horng Kao, Professor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and Roadmap Concept in Chronic Hepatitis B Treatment, run by National Taiwan University Hospital at 1 site in Taiwan.
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 9 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 1 site in Taiwan. 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.
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?
PCR negativity (time frame: week 52). The study lists 4 primary outcomes in all. 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 9 Oct 2013.