Chronic Hepatitis BPhase 3NCT00131742
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
A Phase 3 study testing telbivudine and lamivudine in people with Chronic Hepatitis B, run by Novartis at 1 site in China.
Trial summary
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- telbivudine and lamivudine
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jul 2004to Jan 2007
- Phase
- Phase 3
- 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Documented clinical history compatible with chronic hepatitis B infection
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
- Conditions
- Chronic Hepatitis B
- Being tested
- telbivudine, lamivudine
- 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
lamivudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionJan 2007
- Study completionJan 2007
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131742
- Sponsor's protocol ID
- NV-02B-015
- Status last verified
- May 2015
- First submitted
- 18 Aug 2005
- Last updated
- 12 May 2015
- Results posted
- No
Publications
Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54. doi: 10.1002/hep.22075.
PubMed 18080339
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00131742
- Acronym / sponsor ID
- NV-02B-015
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jul 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Aug 2005 (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 being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Documented clinical history compatible with chronic hepatitis B infection
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (4 listed)
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog
- Other protocol-defined 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 |
|---|---|---|
| telbivudine | Drug | – |
| lamivudine | Drug | – |
Primary outcome
Not reported in the source record.
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 12 May 2015.
- Derived from this study: PubMed 18080339Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54. doi: 10.1002/hep.22075.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telbivudine and lamivudine in people with Chronic Hepatitis B, run by Novartis 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 2 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 12 May 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131742, 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 12 May 2015.