Hepatitis BPhase 4NCT00501124
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
A Phase 4 study testing Clevudine and Purified hepatitis B surface antigen in people with Hepatitis B, run by Bukwang Pharmaceutical at 7 sites in South Korea.
Trial summary
A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Clevudine and Purified hepatitis B surface antigen
- How many people
- 70 participants
- Where
- 7 sitesSouth Korea
- Study dates
- May 2007to Jul 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient is between 18 and 60
- Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive.
- Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
- Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of decompensated liver disease or HCC
- ANA > 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
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- Patient is pregnant or breast-feeding.
- Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- 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
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Dankook University Hospital
Anseo-dong, Cheonan Si, Chungcheongnam-do
Soon Chun Hyang University Cheonan Hospital
Bongmyeong-dong, Cheonan Si, Chungcheongnam-do
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daeheung-dong, Jung-gu, Daejeon
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daejeon
Eulji University Hospital
Dunsan 2-dong, Seo-gu, Daejeon
Chungbuk National University Hospital
Gaesin-dong, Cheongju Si Heungdeok-gu, North Chungcheong
Konyang University Hospital
Gasuwon-dong, Seo-gu,, Daejeon
About this study
Official title: Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.
- Conditions
- Hepatitis B
- Being tested
- Clevudine, Purified hepatitis B surface antigen
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
Purified hepatitis B surface antigenBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral Activity: Proportion of patients with HBeAg loss
Measured: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG
Measured: Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48
Secondary outcomes (2)
Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion
Measured: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a
Measured: Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Heon Young Lee, MD. PhD., Principal investigator, Chungnam National University HospitalHyeon Woong Yang, MD. PhD., Principal investigator, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501124
- Sponsor's protocol ID
- L-FMAU-402
- Status last verified
- Aug 2009
- First submitted
- 12 Jul 2007
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
- ClinicalTrials.gov ID
- NCT00501124
- Acronym / sponsor ID
- L-FMAU-402
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2010 (actual)
- First posted
- 13 Jul 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 randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient is between 18 and 60
- Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive.
- Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
- Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
Key exclusion criteria (11 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of decompensated liver disease or HCC
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 |
|---|---|---|
| Clevudine | Drug | – |
| Purified hepatitis B surface antigen | Biological | – |
Primary outcome
Antiviral Activity: Proportion of patients with HBeAg loss
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48
2 secondary outcomes
Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a
Time frame: Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48
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 22 Dec 2010.
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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.
Heon Young Lee, MD. PhD. principal investigator
Chungnam National University Hospital
Hyeon Woong Yang, MD. PhD. principal investigator
Eulji University Hospital
7 sites 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 and Purified hepatitis B surface antigen in people with Hepatitis B, run by Bukwang Pharmaceutical at 7 sites 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 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: finished, as of the sponsor's last update on 22 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does the primary outcome measure?
Antiviral Activity: Proportion of patients with HBeAg loss (time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)). The study lists 2 primary outcomes in all. 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 22 Dec 2010.