Chronic Hepatitis BPhase 4NCT01264354
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
A Phase 4 study testing Clevudine 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg and Clevudine 20mg in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B. 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 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg and Clevudine 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Feb 2013
- 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 is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline.
- Patient has ALT levels ≥ 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.
- Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
- Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
- Patient is coinfected with HCV, HDV or HIV.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
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- Patient with clinical evidence of hepatocellular carcinoma
- Patient with previous liver transplantation
- 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(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
- 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 an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- Being tested
- Clevudine 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg, Clevudine 20mg
- 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.
Clevudine 30mgDrug
Also called Levovir 30mg
Clevudine 30mg
Clevudine 20mg+Adefovir dipivoxil 10mgDrug
Also called Levovir 20mg+Adefovir 10mg
Clevudine 20mg+ Adefovir 10mg
Clevudine 20mgDrug
Also called Levovir 20mg
Clevudine 20mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clevudine 30mg Receives: Drug: Clevudine 30mg |
| 2 | Experimental | Clevudine 20mg+Adefovir dipivoxil 10mg Receives: Drug: Clevudine 20mg+Adefovir dipivoxil 10mg |
| 3 | Experimental | Clevudine 20mg Receives: Drug: Clevudine 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBV DNA levels < 300 copies/mL
Measured: 24 week
Secondary outcomes (4)
The change of HBV DNA form the baseline
(log copies/mL)
Measured: 24week, 48week, 96week
Proportion of patients with HBV DNA < 300 copies/mL
Measured: 48week, 96week
Proportion of patients with ALT normalization
Measured: 24week, 48week, 96week
Proportion of patients with HBeAg loss and/or seroconversion
Measured: 96 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionFeb 2013
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264354
- Sponsor's protocol ID
- CLV-412
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- 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
- An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01264354
- Acronym / sponsor ID
- CLV-412
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 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 an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Clevudine 30mgClevudine 30mg |
| 2 | Experimental | Drug: Clevudine 20mg+Adefovir dipivoxil 10mgClevudine 20mg+Adefovir dipivoxil 10mg |
| 3 | Experimental | Drug: Clevudine 20mgClevudine 20mg |
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 is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline.
- Patient has ALT levels ≥ 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 (13 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
- Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
- Patient is coinfected with HCV, 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 30mgAlso: Levovir 30mgClevudine 30mg | Drug | 1 |
| Clevudine 20mg+Adefovir dipivoxil 10mgAlso: Levovir 20mg+Adefovir 10mgClevudine 20mg+ Adefovir 10mg | Drug | 2 |
| Clevudine 20mgAlso: Levovir 20mgClevudine 20mg | Drug | 3 |
Primary outcome
Proportion of patients with HBV DNA levels < 300 copies/mL
Time frame: 24 week
4 secondary outcomes
The change of HBV DNA form the baseline
Time frame: 24week, 48week, 96week
Proportion of patients with HBV DNA < 300 copies/mL
Time frame: 48week, 96week
Proportion of patients with ALT normalization
Time frame: 24week, 48week, 96week
Proportion of patients with HBeAg loss and/or seroconversion
Time frame: 96 Week
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 18 Dec 2014.
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
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 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg and Clevudine 20mg 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 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 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 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 levels < 300 copies/mL (time frame: 24 week). 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.