HBeAg(-) Chronic Hepatitis B With Compensated Liver FunctionPhase 4NCT00641082
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
A Phase 4 study testing Clevudine and Adefovir dipivoxil in people with HBeAg(-) Chronic Hepatitis B With Compensated Liver Function, run by Bukwang Pharmaceutical at 2 sites in South Korea.
Trial summary
A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
- What is being tested?
- Clevudine and Adefovir dipivoxil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2008to Mar 2012
- Phase
- Phase 4
- 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
- Patient is documented to be HBsAg positive for > 6 months.
- Patient with compensated hepatic function.
- Nucleoside treatment-naÃ-ve subjects of either gender
- Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
- Patient has ALT levels which are in the range of 2 x ULN and < 10 X ULN
- Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Who cannot join
- Patient is currently receiving antiviral or corticosteroid therapy.
- Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, 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.
- Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- 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.
- Patient is coinfected with HCV, HDV or HIV.
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- Patient with following clinical evidence
- Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
- Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
- Previous organ transplantation
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- 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.
- Patient has α-Fetoprotein more than 100ng/mL
- Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/mm3
- 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
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Bundang
Seoul National University Hospital
Seoul
About this study
A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
- Being tested
- Clevudine, Adefovir dipivoxil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
Also called Levovir
30mg for 48 weeks
Adefovir dipivoxilDrug
Also called Hepsera
10mg for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clevudine Receives: Drug: Clevudine |
| 2 | Active comparator | Adefovir Receives: Drug: Adefovir dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBV DNA below 300copies/mL
Measured: at week 48
Secondary outcomes (4)
The change of HBV DNA from the baseline
Measured: at week 24, 48
Proportion of patients with HBV DNA below LOD of RT-PCR
Measured: at week 24, 48
ALT normalization rate
Measured: at week 24, 48
Proportion of patients with viral breakthrough during 48-week treatment period
Measured: at week 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBeAg(-) Chronic Hepatitis B With Compensated Liver FunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641082
- Sponsor's protocol ID
- CLV-401
- Status last verified
- Apr 2012
- First submitted
- 5 Mar 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
- ClinicalTrials.gov ID
- NCT00641082
- Acronym / sponsor ID
- CLV-401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2012 (actual)
- First posted
- 21 Mar 2008 (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.
A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ClevudineClevudine |
| 2 | Active comparator | Drug: Adefovir dipivoxilAdefovir |
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
- Patient is documented to be HBsAg positive for > 6 months.
- Patient with compensated hepatic function.
- Nucleoside treatment-naÃ-ve subjects of either gender
- Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
Key exclusion criteria (16 listed)
- Patient is currently receiving antiviral or corticosteroid therapy.
- Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, 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.
- Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- 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.
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 |
|---|---|---|
| ClevudineAlso: Levovir30mg for 48 weeks | Drug | 1 |
| Adefovir dipivoxilAlso: Hepsera10mg for 48 weeks | Drug | 2 |
Primary outcome
Proportion of patients with HBV DNA below 300copies/mL
Time frame: at week 48
4 secondary outcomes
The change of HBV DNA from the baseline
Time frame: at week 24, 48
Proportion of patients with HBV DNA below LOD of RT-PCR
Time frame: at week 24, 48
ALT normalization rate
Time frame: at week 24, 48
Proportion of patients with viral breakthrough during 48-week treatment period
Time frame: at week 24, 48
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 25 Apr 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clevudine and Adefovir dipivoxil in people with HBeAg(-) Chronic Hepatitis B With Compensated Liver Function, run by Bukwang Pharmaceutical at 2 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 7 inclusion and 16 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 25 Apr 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients with HBV DNA below 300copies/mL (time frame: at week 48). 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 25 Apr 2012.