Chronic Hepatitis BPhase 3NCT01192854
An Study of Efficacy and Safety of Clevudine
A Phase 3 study testing Clevudine and Adefovir in people with Chronic Hepatitis B, run by Eisai Co., Ltd. at 1 site in China.
Trial summary
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Clevudine and Adefovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
- Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
- Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
- Poorly controlled type I or type 2 diabetes mellitus
- Donation or loss more than 400 ml blood within 60 days of baseline.
- Known serious allergies to nucleoside/nucleotide analogs.
- Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
- Conditions
- Chronic Hepatitis B
- Being tested
- Clevudine, Adefovir
- Keywords
- Clevudine, efficacy, safety, chronic hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
Clevudine flexible dosages of 30 mg/day
AdefovirDrug
Adefovir flexible dosages of 10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Clevudine |
| 2 | Active comparator | Not described Receives: Drug: Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
Measured: 48 weeks
Histological response
Measured: 48 weeks
Secondary outcomes (2)
Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.
Measured: 48 weeks
Percent of patients with normalization of alanine aminotransferase (ALT) at week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, Principal investigator, Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192854
- Sponsor's protocol ID
- XY3-III-CLV-1001A02.4
- Status last verified
- Jul 2011
- First submitted
- 30 Aug 2010
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine
- ClinicalTrials.gov ID
- NCT01192854
- Acronym / sponsor ID
- XY3-III-CLV-1001A02.4
- Conditions
- Chronic Hepatitis B
- Keywords
- Clevudine, efficacy, safety, chronic hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Sep 2010 (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.
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
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: Clevudine |
| 2 | Active comparator | Drug: Adefovir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
- Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
- Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
- Poorly controlled type I or type 2 diabetes mellitus
- Donation or loss more than 400 ml blood within 60 days of baseline.
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 |
|---|---|---|
| ClevudineClevudine flexible dosages of 30 mg/day | Drug | 1 |
| AdefovirAdefovir flexible dosages of 10 mg/day | Drug | 2 |
Primary outcome
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
Time frame: 48 weeks
Histological response
Time frame: 48 weeks
2 secondary outcomes
Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.
Time frame: 48 weeks
Percent of patients with normalization of alanine aminotransferase (ALT) at week 48
Time frame: 48 weeks
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 14 May 2013.
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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.
Guoping Yang principal investigator
Xiangya Hospital
1 site 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 and Adefovir in people with Chronic Hepatitis B, run by Eisai Co., Ltd. at 1 site in China.
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 0 inclusion and 7 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. (time frame: 48 weeks). 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 14 May 2013; AzTrials last refreshed its copy on 26 Oct 2026.