Hepatitis BNCT00362674
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
An observational study of Hepatitis B, run by Bukwang Pharmaceutical at 27 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- How many people
- Not given
- Where
- 27 sitesSouth Korea
- Study dates
- Jun 2005to not given
- Phase
- Observational
- 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
- Child, Adult, Older adult
Study population: the patients who completed the previous 301, 302 and 303 studies with clevudine
Who may be able to join
- The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
- Patients with 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 at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.
Who cannot join
- Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients co-infected with HCV, HDV or HIV.
- Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.
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- Patients who were pregnant or breast-feeding.
- Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, 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 who were not suitable to the study if judged by an investigator.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
South Korea27 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
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
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul
Nowon Eulji Hospital
Hagyeil-tong, Nowon-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
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu
Ehwa Womans University Mokdong Hospital
Mok-dong, 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, 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, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.
- Conditions
- Hepatitis B
- Medical subject headings
- Hepatitis B
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 2005
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
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
- NCT00362674
- Sponsor's protocol ID
- CLV-304
- Status last verified
- Dec 2010
- 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, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial
- ClinicalTrials.gov ID
- NCT00362674
- Acronym / sponsor ID
- CLV-304
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- 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 evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- the patients who completed the previous 301, 302 and 303 studies with clevudine
Key inclusion criteria (5 listed)
- The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
- Patients with 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 at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.
Key exclusion criteria (9 listed)
- Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
- 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.
Primary outcome
Not reported in the source record.
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 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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Bukwang Pharmaceutical at 27 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 5 inclusion and 9 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 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 27 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.
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.
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.