Hepatitis B, ChronicPhase 3EBERESTNCT00640588
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
A Phase 3 study testing Telbivudine and oral adefovir in people with Hepatitis B, Chronic, run by Novartis Pharmaceuticals at 1 site in Spain.
Trial summary
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Telbivudine and oral adefovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2008to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age.
- Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
Who cannot join
- Co-infection with HCV, HDV, or HIV.
- Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
- History of hepatic decompensation
- History of malignancy
- Patient has one or more additional known primary or secondary causes of liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
- Conditions
- Hepatitis B, Chronic
- Being tested
- Telbivudine, oral adefovir
- Keywords
- Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance
- Medical subject headings
- Hepatitis B, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
Also called Sebivo, Tyzeka, Hepsera
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
oral adefovirDrug
Also called adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Telbivudine Receives: Drug: Telbivudine |
| 2 | Active comparator | Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks Receives: Drug: oral adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Measured: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Secondary outcomes (1)
Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline
Measured: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640588
- Sponsor's protocol ID
- CLDT600AES01
- Acronym
- EBEREST
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2008
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine
- ClinicalTrials.gov ID
- NCT00640588
- Acronym / sponsor ID
- EBEREST / CLDT600AES01
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Mar 2008 (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 will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TelbivudineTelbivudine |
| 2 | Active comparator | Drug: oral adefovirArm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, at least 18 years of age.
- Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
Key exclusion criteria (5 listed)
- Co-infection with HCV, HDV, or HIV.
- Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
- History of hepatic decompensation
- History of malignancy
- Patient has one or more additional known primary or secondary causes of liver disease
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, Tyzeka, HepseraArm 1: 600 mg/day, oral telbivudina for 24 weeks | Drug | 1 |
| oral adefovirAlso: adefovirArm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks | Drug | 2 |
Primary outcome
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
1 secondary outcome
Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline
Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
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 28 Mar 2017.
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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.
Novartis study director
Novartis
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 oral adefovir in people with Hepatitis B, Chronic, run by Novartis Pharmaceuticals at 1 site in Spain.
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 5 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 28 Mar 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 Spain. 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.
What does the primary outcome measure?
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks (time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks). 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 28 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.