Chronic Hepatitis BPhase 4NCT00798460
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
A Phase 4 study testing adefovir, clevudine and lamivudine in people with Chronic Hepatitis B, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- adefovir, clevudine and lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Nov 2010
- 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
- HBsAg positive and anti-HBs negative more than 6 months
- YMDD mutation (+)during lamivudine therapy
- Serum ALT more than two times upper normal value
Who cannot join
- HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
- The sign of decompensated liver disease
- Pregnant or lactating woman
- The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
- Serum creatinine more than 1.5 times upper normal limit value
- The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.
Read the detailed description
Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.
In detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.
- Conditions
- Chronic Hepatitis B
- Being tested
- adefovir, clevudine, lamivudine
- Keywords
- Chronic hepatitis B, lamivudine resistance, 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.
adefovirDrug
Also called Hepsera
adefovir 10mg
clevudineDrug
Also called Levovir
clevudine 30mg
lamivudineDrug
Also called Zeffix
lamivudine 100mg
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine plus adefovir | Active comparator | Not described Receives: Drug: adefovir; Drug: lamivudine |
| Clevudine plus adefovir | Active comparator | Not described Receives: Drug: adefovir; Drug: clevudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA titer < 300 copies/mL
Measured: 48 week
Secondary outcomes (1)
Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010
- Study completionNov 2010
Why it stopped: could not enroll patients
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Bukwang Pharmaceutical
- Investigators
- June Sung Lee, M.D., Principal investigator, Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798460
- Sponsor's protocol ID
- IB-0809-055
- Status last verified
- Jun 2011
- First submitted
- 25 Nov 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
- ClinicalTrials.gov ID
- NCT00798460
- Acronym / sponsor ID
- IB-0809-055
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic hepatitis B, lamivudine resistance, clevudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: could not enroll patients
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Bukwang Pharmaceutical
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Nov 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.
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.
Detailed description
Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.
In detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine plus adefovir | Active comparator | Drug: adefovir, Drug: lamivudine |
| Clevudine plus adefovir | Active comparator | Drug: adefovir, Drug: clevudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HBsAg positive and anti-HBs negative more than 6 months
- YMDD mutation (+)during lamivudine therapy
- Serum ALT more than two times upper normal value
Key exclusion criteria (7 listed)
- HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
- The sign of decompensated liver disease
- Pregnant or lactating woman
- The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
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 |
|---|---|---|
| adefovirAlso: Hepseraadefovir 10mg | Drug | Clevudine plus adefovir, Lamivudine plus adefovir |
| clevudineAlso: Levovirclevudine 30mg | Drug | Clevudine plus adefovir |
| lamivudineAlso: Zeffixlamivudine 100mg | Drug | Lamivudine plus adefovir |
Primary outcome
HBV DNA titer < 300 copies/mL
Time frame: 48 week
1 secondary outcome
Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance
Time frame: 48 week
Results and safety
The study was stopped early (reason given: could not enroll patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
June Sung Lee, M.D. principal investigator
Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706
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 adefovir, clevudine and lamivudine in people with Chronic Hepatitis B, run by Inje University 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 3 inclusion and 7 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 23 Jun 2011. 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 was stopped early (reason given: could not enroll patients). 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?
HBV DNA titer < 300 copies/mL (time frame: 48 week). 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 23 Jun 2011.