Hepatitis BPhase 3NCT00313274
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
A Phase 3 study testing Clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 30 sites in South Korea.
Trial summary
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative 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
- How many people
- 80 participants
- Where
- 30 sitesSouth Korea
- Study dates
- Jul 2003to Dec 2004
- Phase
- Phase 3
- 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
- Patients who were between 18 and 60, inclusive
- Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg negative and HBeAb positive.
- Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) 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 with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients coinfected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
- Patients who were pregnant or breast-feeding.
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- Patients who were unwilling to use an "effective" method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
- Patients with a clinically relevant history of abuse of alcohol or drugs.
- Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
- Patients with 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
30 sites in 1 country.
30 sites in 1 country
South Korea30 sites
Pusan National University Hospital
Ami-dong, Seo-gu, Pusan
Kosin Medical Center
Amnam-dong, Seo-gu, Pusan
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul
KangNam St. Mary's Hospital
Banpo-dong, Seocho-gu, Seoul
St. Holly Family Mary's Hospital
Bucheonae, Kyounggi-do
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon
St. Vincent's Hospital
Chi-dong, Paldal-gu, Suwon
Yeungnam University Medical Center
Dae Myoung-dong, Nam-gu, Taegu
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul
Pusan Paik Hospital
Gaegeum-dong, Busan
Nowon Eulji Hospital
Hagyeil-tong, Nowon-gu, Seoul
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju-si
Soon Chun Hyang University Hospital
Hannam-dong, Yongsan-gu, Seoul
Wonkwang University Hospital
Iksan, Jeollabuk-do
National Cancer Center
Ilsan-gu, Kyounggi-do
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul
Gil Medical Center
Incheon, Namdong-Gu
Seoul Paik Hospital
Jeo-dong, Seoul
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
Keimyumg University Dongsan Medical Center
Jung-gu, Daegu
Ehwa Womans University Mokdong Hospital
Mokdong, Yangcheon-gu, Seoul
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu, Seoul
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do
Korea University Guro Hospital
Seoul, Guro-gu
Seoul National University Hospital
Seoul, Jongno-Gu
St. Mary's Hospital
Seoul, Yungdungpo-Gu
Severance Hospital
Shinchon- Dong, Seodaemun-gu, Seoul
Inha University Hospital
Sinhŭng-dong, Jung-gu, Incheon
Yongdong Severance Hospital
Togok-tong, Kangnam-gu, Seoul
About this study
Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
- Conditions
- Hepatitis B
- Being tested
- Clevudine
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy:
Antiviral activity (change from baseline in HBV DNA (log 10))
Safety:
Laboratory tests
Adverse Events
Vital signs
ECG
Secondary outcomes (3)
Efficacy
Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
Biochemical improvement (e.g. ALT normalization )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startJul 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyo-Suk Lee, MD. PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313274
- Sponsor's protocol ID
- L-FMAU-302
- Status last verified
- Apr 2006
- First submitted
- 11 Apr 2006
- Last updated
- 1 Feb 2017
- Results posted
- No
Publications
Yoo BC, Kim JH, Kim TH, Koh KC, Um SH, Kim YS, Lee KS, Han BH, Chon CY, Han JY, Ryu SH, Kim HC, Byun KS, Hwang SG, Kim BI, Cho M, Yoo K, Lee HJ, Hwang JS, Kim YS, Lee YS, Choi SK, Lee YJ, Yang JM, Park JW, Lee MS, Kim DG, Chung YH, Cho SH, Choi JY, Kweon YO, Lee HY, Jeong SH, Yoo HW, Lee HS. Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology. 2007 Oct;46(4):1041-8. doi: 10.1002/hep.21800.
PubMed 17647293
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00313274
- Acronym / sponsor ID
- L-FMAU-302
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Dec 2004
- First posted
- 12 Apr 2006 (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 safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who were between 18 and 60, inclusive
- Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg negative and HBeAb positive.
- Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) 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.
Key exclusion criteria (11 listed)
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients coinfected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
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 | – |
Primary outcome
Efficacy:
Antiviral activity (change from baseline in HBV DNA (log 10))
Safety:
Laboratory tests
Adverse Events
Vital signs
ECG
3 secondary outcomes
Efficacy
Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
Biochemical improvement (e.g. ALT normalization )
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 17647293Yoo BC, Kim JH, Kim TH, Koh KC, Um SH, Kim YS, Lee KS, Han BH, Chon CY, Han JY, Ryu SH, Kim HC, Byun KS, Hwang SG, Kim BI, Cho M, Yoo K, Lee HJ, Hwang JS, Kim YS, Lee YS, Choi SK, Lee YJ, Yang JM, Park JW, Lee MS, Kim DG, Chung YH, Cho SH, Choi JY, Kweon YO, Lee HY, Jeong SH, Yoo HW, Lee HS. Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology. 2007 Oct;46(4):1041-8. doi: 10.1002/hep.21800.
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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.
Hyo-Suk Lee, MD. PhD principal investigator
Seoul National University Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 30 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 7 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: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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. 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?
Efficacy:. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313274, which also lists 1 linked publication.
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 1 Feb 2017.