Hepatitis BPhase 3NCT00362505
Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
A Phase 3 study testing Clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 32 sites in South Korea.
Trial summary
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Clevudine
- How many people
- Not given
- Where
- 32 sitesSouth Korea
- Study dates
- Jun 2004to Mar 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is between 18 and 60, inclusive
- Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
- Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
- Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
- Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
- Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir 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.
Show all 14Show fewer
- Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein > 50 ng/mL
- 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. For males, condoms should be used. Females must 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)
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, 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]
- 13.Patient whom investigator consider is not suitable in this study
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
South Korea32 sites
Pusan National University Hospital
Ami-dong, Seo-gu, Busan
Kosin Medical Center
Amnam-dong, Seo-gu, Busan
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
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul
Yeungnam University Medical Center
Daemyoung-dong, Nam-gu, Daegu
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daechon
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul
Pusan Paik Hospital
Gaegeum-dong, Busan
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju
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
St. Vincent's Hospital
Ji-dong,, Paldal-gu, Suwon
Kyungpook National University Medical Hospital
Jung-gu, Daegu
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu
Ehwa Womans University Mokdong Hospital
Mok-dong, Yangcheon-gu, Seoul
St. Holly Family Mary's Hospital
Puch’un, 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, 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
Sinhung-dong, Jung-gu, Incheon
About this study
Official title: An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
- 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; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
Secondary outcomes (1)
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 posted10 Aug 2006 (estimated)
- Study startJun 2004
- Study completionMar 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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
- NCT00362505
- Sponsor's protocol ID
- L-FMAU-303
- Status last verified
- Jun 2006
- First submitted
- 8 Aug 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
- An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
- ClinicalTrials.gov ID
- NCT00362505
- Acronym / sponsor ID
- L-FMAU-303
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Mar 2006
- First posted
- 10 Aug 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 clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is between 18 and 60, inclusive
- Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
- Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
- Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
- Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
Key exclusion criteria (14 listed)
- Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
- Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
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; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
1 secondary outcome
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
32 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 32 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 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 32 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; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.. 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.