Hepatitis BPhase 3NCT00362635
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
A Phase 3 study testing Clevudine in people with Hepatitis B, run by Bukwang Pharmaceutical at 2 sites in Hong Kong.
Trial summary
The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection. 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
- 92 participants
- Where
- 2 sitesHong Kong
- Study dates
- Aug 2006to Dec 2011
- 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
- Patient is between 18 and 60, inclusive.
- Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
- Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
- Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
- Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
- Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
- Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is co-infected with HCV or HIV.
- Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
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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.
- Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
- Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Road
Alice Ho Miu Ling Nethersole Hospital
Tai Po, New Territories
About this study
Official title: A Double-blinded and Randomised Study to Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection
The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
- 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: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Safety: Laboratory tests, Adverse Events, Physical examination
Secondary outcomes (5)
Efficacy:
Viral kinetics of HBV DNA suppression
Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
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 startAug 2006
- Primary completionDec 2011
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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- George KK Lau, M.D., Principal investigator, Queen Mary Hospital, Hong KongNancy Leung, M.D., Principal investigator, Alice Ho Miu Ling Nethersole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362635
- Sponsor's protocol ID
- CLV-310
- Status last verified
- Jul 2012
- First submitted
- 8 Aug 2006
- Last updated
- 26 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded and Randomised Study to Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT00362635
- Acronym / sponsor ID
- CLV-310
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Dec 2011 (actual)
- 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 compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
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)
- Patient is between 18 and 60, inclusive.
- Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
- Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
- Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
- Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
Key exclusion criteria (13 listed)
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
- Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is co-infected with HCV 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: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Safety: Laboratory tests, Adverse Events, Physical examination
5 secondary outcomes
Efficacy:
Viral kinetics of HBV DNA suppression
Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
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 26 Jul 2012.
- Unique trial number : HKCTR-250Link provided by the sponsor.
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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.
George KK Lau, M.D. principal investigator
Queen Mary Hospital, Hong Kong
Nancy Leung, M.D. principal investigator
Alice Ho Miu Ling Nethersole Hospital
2 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 2 sites in Hong Kong.
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 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: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 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.
What does the primary outcome measure?
Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR. 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 26 Jul 2012.