Hepatitis BPhase 2NCT00362700
Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201
A Phase 2 study testing Clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 7 sites in South Korea.
Trial summary
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine 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
- 33 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Jul 2003to Oct 2005
- Phase
- Phase 2
- 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
- Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
- Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test 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.
- Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in HBV DNA at Week 48
Who cannot join
- HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
- Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
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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. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a 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, neurological, cardiovascular, oncologic or allergic disease.
- 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
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul
Ehwa Womans University Mokdong Hospital
Mok-dong, Yangcheon-gu, Seoul
Asan Medical Center
P’ungnabi-dong, Songpa-Gu, Seoul
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul
Korea University Guro Hospital
Seoul, Guro-gu
Seoul National University Hospital
Seoul, Jongno-Gu
About this study
Official title: An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
- 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.
Antiviral activity- Change from baseline in HBV DNA (log10)
Safety- Laboratory tests, Adverse Events, Vital Signs, ECG
Secondary outcomes (3)
Antiviral activity- Proportion of patients with HBV DNA below the assay Limit of Detection(<4,700 copies/mL by Digene Hybrid Capture II)
Biochemical improvement (ALT normalization)
Serology: Proportion of patients with HBeAg loss,Seroconversion rate (HBeAg loss and anti-HBe gain)
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 startJul 2003
- Study completionOct 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyo Suk Lee, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362700
- Sponsor's protocol ID
- L-FMAU-204
- 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 II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201
- ClinicalTrials.gov ID
- NCT00362700
- Acronym / sponsor ID
- L-FMAU-204
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Oct 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 determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
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 (4 listed)
- Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
- Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test 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.
- Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in HBV DNA at Week 48
Key exclusion criteria (12 listed)
- HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
- Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected 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
Antiviral activity- Change from baseline in HBV DNA (log10)
Safety- Laboratory tests, Adverse Events, Vital Signs, ECG
3 secondary outcomes
Antiviral activity- Proportion of patients with HBV DNA below the assay Limit of Detection(<4,700 copies/mL by Digene Hybrid Capture II)
Biochemical improvement (ALT normalization)
Serology: Proportion of patients with HBeAg loss,Seroconversion rate (HBeAg loss and anti-HBe gain)
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, M.D., Ph.D. principal investigator
Seoul National 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 2 study testing Clevudine 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 4 inclusion and 12 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Antiviral activity- Change from baseline in HBV DNA (log10). 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.