Hepatitis, ChronicPhase 4SASL28NCT01005238
Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine
A Phase 4 study testing Lamivudine and Telbivudine in people with Hepatitis, Chronic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Chronic
- What is being tested?
- Lamivudine and Telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, > 18 (having completed their 18th birthday). There is no upper limit of age
- Documented HBeAg negative CHB
- HBsAg positive > 6 months
- HBV DNA > 2000 IU/mL
- Patient is willing and able to comply with the study drug regimen and all other study requirements.
- Written informed consent
- Anti-viral HBV treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening
Who cannot join
- Decompensated liver cirrhosis according to the judgment of the local investigator
- Hepatocellular carcinoma
- History of or laboratory signs of co-infection with HIV or HCV, HDV
- Previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an exclusion criteria, but has to be stopped one month before screening)
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients
- Any medical condition that requires frequent or prolonged use of systemic corticosteroids (inhaled, topic or intra-articular corticosteroids are allowed)
Show all 22Show fewer
- Any medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
- Current abuse of alcohol or illicit drugs.
- Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- Any other concurrent medical or social condition which is, in the opinion of the investigator, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
- Any of the following laboratory values during Screening:
- Hemoglobin (HGB) <11 g/dL for men or <10 g/dL for women
- Total WBC <3000/mm3
- Absolute neutrophil count (ANC) <1,500.mm3
- Platelet count <50'000/mm3
- Serum amylase or lipase ≥ 1.5 x ULN
- Serum albumin <3 g/dL
- Total bilirubin > 51 μmol/L (> 3.0 mg/dL)
- Estimated calculated serum creatinine clearance < 50 mL/min using the Cockcroft-Gault method using actual or ideal body weight whichever is less (Cockcroft and Gault 1976)
- AFP (alpha-fetoprotein) > 100 ng/mL
- ALT > 10x ULN
- Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) during Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy
The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.
- Conditions
- Hepatitis, Chronic
- Being tested
- Lamivudine, Telbivudine
- Medical subject headings
- Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
TelbivudineDrug
| Study group | Role | What they receive |
|---|---|---|
| telbivudine | Active comparator | patients in this arm will continue to take telbivudine Receives: Drug: Telbivudine |
| lamivudine | Experimental | patients in this arm will take lamivudine Receives: Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.
Measured: The primary efficacy endpoint is the rate of viral breakthrough at week 108.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2014
Why it stopped: unsufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Heim, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005238
- Sponsor's protocol ID
- SASL28
- Acronym
- SASL28
- Status last verified
- Mar 2015
- First submitted
- 29 Oct 2009
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy
- ClinicalTrials.gov ID
- NCT01005238
- Acronym / sponsor ID
- SASL28 / SASL28
- Conditions
- Hepatitis, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unsufficient patient recruitment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- First posted
- 30 Oct 2009 (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.
The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telbivudine | Active comparator | Drug: Telbivudinepatients in this arm will continue to take telbivudine |
| lamivudine | Experimental | Drug: Lamivudinepatients in this arm will take lamivudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients, > 18 (having completed their 18th birthday). There is no upper limit of age
- Documented HBeAg negative CHB
- HBsAg positive > 6 months
- HBV DNA > 2000 IU/mL
- Patient is willing and able to comply with the study drug regimen and all other study requirements.
Key exclusion criteria (22 listed)
- Decompensated liver cirrhosis according to the judgment of the local investigator
- Hepatocellular carcinoma
- History of or laboratory signs of co-infection with HIV or HCV, HDV
- Previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an exclusion criteria, but has to be stopped one month before screening)
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients
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 |
|---|---|---|
| Lamivudine | Drug | lamivudine |
| Telbivudine | Drug | telbivudine |
Primary outcome
The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.
Time frame: The primary efficacy endpoint is the rate of viral breakthrough at week 108.
Results and safety
The study was stopped early (reason given: unsufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Markus Heim, Prof. principal investigator
University Hospital, Basel, Switzerland
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, Chronic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Mar 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 Switzerland. 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 stopped early (reason given: unsufficient patient recruitment). Results are not available in the source record.
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?
The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL. (time frame: The primary efficacy endpoint is the rate of viral breakthrough at week 108.). 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 10 Mar 2015.