Hepatitis B, ChronicPhase 4EVDNCT00710216
Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
A Phase 4 study testing Lamivudine and Telbivudine in people with Hepatitis B, Chronic, run by University of Ulm at 1 site in Germany.
Trial summary
This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Lamivudine and Telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented compensated HBeAg-positive or negative chronic hepatitis B
- Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml
- Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
- Negative urine pregnancy test with fertile women
- Willingness to use a recognized method of contraception
- Able to comply with study regimen and provide written informed consent
Who cannot join
- Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
- Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
- Pregnant or breastfeeding women or women
- Simultaneous participation in other clinical trials or in the past three months
- Co-infected with HCV, HDV, HIV
- Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
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- Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml)
- Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
- Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
- Lack of willingness or inability to consent in writing
- Concurrent condition likely to preclude compliance with schedule of evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study)
This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Lamivudine, Telbivudine
- Keywords
- Viral kinetics, Viral dynamics, 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.
LamivudineDrug
Also called Zeffix, Epivir, LAM, 134678-17-4
100 mg/day
TelbivudineDrug
Also called Sebivo, Tyzeka, L-dT, 3424-98-4
600 mg/day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Lamivudine |
| B | Experimental | Not described Receives: Drug: Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
Measured: 2 weeks
Secondary outcomes (6)
Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
Measured: 12 weeks
Influence of HBeAg status to the decrease in viral load
Measured: 12 weeks
Influence of HBV genotype to the decrease in viral load
Measured: 12 weeks
Change in ALT and AST levels from Baseline to Week 12
Measured: 12 weeks
Development of viral resistance and treatment failure during the study and subsequent course of observation
Measured: 6 month
Safety assessed by adverse events and laboratory values
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
Why it stopped: Sponsor withdraw
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Nektarios Dikopoulos, MD, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710216
- Sponsor's protocol ID
- EVD-001
- Acronym
- EVD
- Status last verified
- Apr 2009
- First submitted
- 2 Jul 2008
- Last updated
- 20 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study)
- ClinicalTrials.gov ID
- NCT00710216
- Acronym / sponsor ID
- EVD / EVD-001
- Conditions
- Hepatitis B, Chronic
- Keywords
- Viral kinetics, Viral dynamics, Telbivudine, Lamivudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdraw
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Novartis
- First posted
- 4 Jul 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 examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Lamivudine |
| B | Experimental | Drug: Telbivudine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented compensated HBeAg-positive or negative chronic hepatitis B
- Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml
- Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
- Negative urine pregnancy test with fertile women
- Willingness to use a recognized method of contraception
Key exclusion criteria (11 listed)
- Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
- Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
- Pregnant or breastfeeding women or women
- Simultaneous participation in other clinical trials or in the past three months
- Co-infected with HCV, HDV, HIV
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 |
|---|---|---|
| LamivudineAlso: Zeffix, Epivir, LAM, 134678-17-4100 mg/day | Drug | A |
| TelbivudineAlso: Sebivo, Tyzeka, L-dT, 3424-98-4600 mg/day | Drug | B |
Primary outcome
Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
Time frame: 2 weeks
6 secondary outcomes
Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy
Time frame: 12 weeks
Influence of HBeAg status to the decrease in viral load
Time frame: 12 weeks
Influence of HBV genotype to the decrease in viral load
Time frame: 12 weeks
Change in ALT and AST levels from Baseline to Week 12
Time frame: 12 weeks
Development of viral resistance and treatment failure during the study and subsequent course of observation
Time frame: 6 month
Safety assessed by adverse events and laboratory values
Time frame: 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- University Hospital UlmLink provided by the sponsor.
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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.
Nektarios Dikopoulos, MD principal investigator
University Hospital Ulm
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 Lamivudine and Telbivudine in people with Hepatitis B, Chronic, run by University of Ulm at 1 site in Germany.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 20 Apr 2009. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). (time frame: 2 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 20 Apr 2009.