Chronic Hepatitis BPhase 4NCT01266005
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
A Phase 4 study testing Clevudine and Entecavir in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Clevudine and Entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is older than 18.
- Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
- Patient who is HBeAg negative.
- Patient with ALT≥1×ULN.
- Patient who 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, cytotoxic or corticosteroid therapy.
- Patient is treated with interferon for the previous 6 months.
- Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
- Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
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- Patient has a history of organ transplantation.
- Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- 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
1 site in 1 country.
About this study
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- Clevudine, Entecavir
- Keywords
- HBe Ag(-) 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
Also called Levovir
30mg,QD
EntecavirDrug
Also called Baraclude
0.5mg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clevudine 30mg Receives: Drug: Clevudine |
| 2 | Active comparator | Entecavir 0.5mg Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic cccDNA reduction from baseline
Measured: week 48
Secondary outcomes (5)
Proportion of patients with HBV DNA below LOD by real-time PCR
Measured: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of HBV DNA level from baseline
Measured: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
ALT normalization
Measured: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of sAg titer from baseline
Measured: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Proportion of maintaining sustained effect
Measured: every 8 weeks during follow-up period(48weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2013
- Study completionJan 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266005
- Sponsor's protocol ID
- CLV-410
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
- ClinicalTrials.gov ID
- NCT01266005
- Acronym / sponsor ID
- CLV-410
- Conditions
- Chronic Hepatitis B
- Keywords
- HBe Ag(-) Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Dec 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.
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ClevudineClevudine 30mg |
| 2 | Active comparator | Drug: EntecavirEntecavir 0.5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who is older than 18.
- Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
- Patient who is HBeAg negative.
- Patient with ALT≥1×ULN.
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (12 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patient is treated with interferon for the previous 6 months.
- Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
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,QD | Drug | 1 |
| EntecavirAlso: Baraclude0.5mg QD | Drug | 2 |
Primary outcome
Intrahepatic cccDNA reduction from baseline
Time frame: week 48
5 secondary outcomes
Proportion of patients with HBV DNA below LOD by real-time PCR
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of HBV DNA level from baseline
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
ALT normalization
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of sAg titer from baseline
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Proportion of maintaining sustained effect
Time frame: every 8 weeks during follow-up period(48weeks)
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 18 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Entecavir in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site 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 5 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 18 Dec 2014. 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 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 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?
Intrahepatic cccDNA reduction from baseline (time frame: 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 18 Dec 2014.