Hepatitis BPhase 2NCT00305019
Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus
A Phase 2 study testing clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 8 sites in South Korea.
Trial summary
The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (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
- 120 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Jul 2002to Mar 2004
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient who is between 18 and 60 years of age, inclusive
- Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.
- Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.
- Evidence of HBsAg (+) for the previous 6 months may include the following:
- documentation of HBsAg (+) for the previous 6 months
- documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
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- IgM anti-HBc negative and IgG anti-HBc positive at screening
- Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
- Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
- Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:
- have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
- continue with period 1 log10 decrease in HBV DNA from baseline.
Who cannot join
- Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
- Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
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- Patient who is pregnant or breast-feeding.
- Patient who is unwilling to use an "effective" method of contraception during the study and for up to 30 days 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., intrauterine device [IUD], barrier methods with spermicide or abstinence)
- Patient who has a clinically relevant history of abuse of alcohol or drugs.
- Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- Patient who has creatinine clearance less than 60 mL/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 found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Kangdong Sacred Heart Hospital
Gildong, Kangdong-Gu, Seoul, 134-701
Korea University Guro Hospital
Guro-dong, Guro-ku, Seoul, 152-703
Samsung Medical Center
Ilwon-dong, Kangnam-Gu, Seoul, 135-710
Ewha Womans University Hospital
Mokdong, Yangchon-Gu, Seoul, 911-1
Asan Medical Center
P’ungnabi-dong, Songpa-Gu, Seoul, 388-1
Yongdong Severance Hospital
Togok-tong, Kangnam-Gu, Seoul, 146-92
Seoul National University
Yeongeon-dong, Jongno-Gu, Seoul, 110-744
St. Mary's Hospital
Youido, Yougdungpo-Gu, Seoul, 150-713
About this study
Official title: A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus
The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (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)
Secondary outcomes (10)
Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
Proportion of patients with hepatitis Be antigen (HBeAg) loss
Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
Biochemical improvement (e.g., ALT normalization)
Safety
Laboratory tests
Adverse Events
Vital Signs
Electrocardiogram (ECG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startJul 2002
- Study completionMar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 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
- NCT00305019
- Sponsor's protocol ID
- L-FMAU-201
- Status last verified
- Apr 2006
- First submitted
- 17 Mar 2006
- Last updated
- 12 Apr 2006
- Results posted
- No
Publications
Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH, Yoo BC. A 12-week clevudine therapy showed potent and durable antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology. 2006 May;43(5):982-8. doi: 10.1002/hep.21166.
PubMed 16628625
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT00305019
- Acronym / sponsor ID
- L-FMAU-201
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Mar 2004
- First posted
- 21 Mar 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 antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (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 (13 listed)
- Patient who is between 18 and 60 years of age, inclusive
- Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.
- Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.
- Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
- Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
Key exclusion criteria (13 listed)
- Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
- Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (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)
10 secondary outcomes
Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
Proportion of patients with hepatitis Be antigen (HBeAg) loss
Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
Biochemical improvement (e.g., ALT normalization)
Safety
Laboratory tests
Adverse Events
Vital Signs
Electrocardiogram (ECG)
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 12 Apr 2006.
- Derived from this study: PubMed 16628625Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH, Yoo BC. A 12-week clevudine therapy showed potent and durable antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology. 2006 May;43(5):982-8. doi: 10.1002/hep.21166.
Related trials for Hepatitis B
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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
8 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 8 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 13 inclusion and 13 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 12 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Efficacy: Change from baseline in HBV DNA (log10). 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 NCT00305019, 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 12 Apr 2006.