Hepatitis BPhase 2NCT00124241
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
A Phase 2 study testing telbivudine and lamivudine in people with Hepatitis B, run by Novartis at 4 sites in 4 countries.
Trial summary
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- telbivudine and lamivudine
- How many people
- Not given
- Where
- 4 sitesin 4 countries
- Study dates
- Start not givento Nov 2005
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
- Patient remains seropositive for hepatitis B surface antigen (HBsAg)
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patient is pregnant or breast-feeding
- Patient has signs of decompensated chronic hepatitis B
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
- Conditions
- Hepatitis B
- Being tested
- telbivudine, lamivudine
- Medical subject headings
- Hepatitis B
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 posted27 Jul 2005 (estimated)
- Primary completionFeb 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- 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
- NCT00124241
- Sponsor's protocol ID
- NV-02B-010
- Status last verified
- May 2015
- First submitted
- 25 Jul 2005
- Last updated
- 12 May 2015
- Results posted
- No
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 IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003
- ClinicalTrials.gov ID
- NCT00124241
- Acronym / sponsor ID
- NV-02B-010
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Primary completion
- Feb 2003 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Jul 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 is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
- Patient remains seropositive for hepatitis B surface antigen (HBsAg)
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Patient is pregnant or breast-feeding
- Patient has signs of decompensated chronic hepatitis B
- 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.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telbivudine and lamivudine in people with Hepatitis B, run by Novartis at 4 sites in 4 countries.
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 3 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 4 sites in United States, Canada, China, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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.