Chronic Hepatitis BPhase 4NCT00558493
Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
A Phase 4 study testing Clevudine in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Clevudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBV DNA > 2,000 copies/mL at screening
- Patients who have compensated liver disease (Child-Pugh score =<6)
- Patients without LMV resistant mutation by RFMP assay
- Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
- Patients who can submit the written consent and comply with the claims postulated of this clinical trial
Who cannot join
- Currently receiving antiviral except LMV or corticosteroid therapy
- Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
- Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
- Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- Patients who is co-infected with HCV, HDV or HIV
- Serious concurrent medical conditions
Show all 9Show fewer
- Prior organ transplantation
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
- [(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dL])[Note: multiply estimates by 0.85 for women]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- Clevudine
- 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.
ClevudineDrug
clevudine 30 mg qd for 24 seeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | switching treatment from lamivudine to clevudine Receives: Drug: Clevudine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558493
- Sponsor's protocol ID
- KB-406
- Other IDs
- KB-406
- Status last verified
- Jul 2012
- First submitted
- 14 Nov 2007
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment
- ClinicalTrials.gov ID
- NCT00558493
- Acronym / sponsor ID
- KB-406
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- First posted
- 15 Nov 2007 (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.
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Clevudineswitching treatment from lamivudine to clevudine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HBV DNA > 2,000 copies/mL at screening
- Patients who have compensated liver disease (Child-Pugh score =<6)
- Patients without LMV resistant mutation by RFMP assay
- Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
- Patients who can submit the written consent and comply with the claims postulated of this clinical trial
Key exclusion criteria (9 listed)
- Currently receiving antiviral except LMV or corticosteroid therapy
- Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
- Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
- Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- Patients who is co-infected with HCV, HDV or 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 |
|---|---|---|
| Clevudineclevudine 30 mg qd for 24 seeks | Drug | 1 |
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 26 Jul 2012.
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Chronic Hepatitis B
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 4 study testing Clevudine in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 9 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 26 Jul 2012. 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 South Korea. 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 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 26 Jul 2012.