Hepatitis BPhase 3NCT00313287
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV
A Phase 3 study testing clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 33 sites in South Korea.
Trial summary
The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV. 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
- 180 participants
- Where
- 33 sitesSouth Korea
- Study dates
- Jun 2003to Nov 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 ³1 x 106 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for > 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg positive.
- Patients with ALT levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.
- Women of child bearing 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 co-infected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/mL
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- Patients who were pregnant or breast-feeding.
- Patients who were unwilling to use an "effective" method of contraception during the treatment 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), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.
- The patients with a benign tumor were 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]
- Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
South Korea33 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. 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
Chungnam National University Hospital
Daesadong, Jung-gu, Daechon
Pusan Paik Hospital
Gaegeum-dong, Busan
Korea Cancer Center Hospital
Gongneungdong, Nowon-gu, Seoul
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
Seoul Paik Hospital
Jeo-dong, Seoul
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
Keimyumg University Dongsan Medical Center
Jung-gu, Daegu
Kyungpook National University Medical Hospital
Jung-gu, Daegu
Ehwa Womans University Mokdong Hospital
Mokdong, Yangcheon-gu, Seoul
St. Holly Family Mary's Hospital
Pucheon, Kyounggi-do
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, Gro-gu
St. Mary's Hospital
Seoul, Yungdungpo-Gu
Seoul National University Hospital
Seoul
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 30 mg QD in Patients Chronically Infected With Hepatitis B Virus
The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
- 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:change from baseline in HBV DNA (log10) at Week 24
Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.
Secondary outcomes (4)
Efficacy:
Proportion of patients with HBV DNA below the assay Limit of Detection
Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
Proportion of 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 startJun 2003
- Study completionNov 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 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
- NCT00313287
- Sponsor's protocol ID
- L-FMAU-301
- Status last verified
- Apr 2006
- First submitted
- 11 Apr 2006
- Last updated
- 1 Feb 2017
- Results posted
- No
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 30 mg QD in Patients Chronically Infected With Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT00313287
- Acronym / sponsor ID
- L-FMAU-301
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Nov 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 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
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 ³1 x 106 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for > 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg positive.
- Patients with ALT levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.
Key exclusion criteria (14 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 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 |
|---|---|---|
| clevudine | Drug | – |
Primary outcome
Efficacy:change from baseline in HBV DNA (log10) at Week 24
Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.
4 secondary outcomes
Efficacy:
Proportion of patients with HBV DNA below the assay Limit of Detection
Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
Proportion of 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.
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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
33 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 33 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 14 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 33 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:change from baseline in HBV DNA (log10) at Week 24. 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 1 Feb 2017.