Hepatitis B Associated Hepatocellular CarcinomaPhase 4NCT01263002
A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC
A Phase 4 study testing clevudine, Adefovir in people with Hepatitis B Associated Hepatocellular Carcinoma, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Associated Hepatocellular Carcinoma
- What is being tested?
- clevudine, Adefovir
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Sep 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 with chronic HBV DNA and/or with symptoms of liver cirrhosis
- Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months.
- Laboratory report proving HBsAg positive or HBeAg positive for at least six months
- IgM anti-HBc negative, IgG anti-HBc positive at screening
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- Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
- Patient has ALT or AST levels >=40 IU/L
- Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
- Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- Patient who is classified as NYHA functional classification grade 1-2. (NYHA;New York Heart Association)
- 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 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 is coinfected with HCV, HDV or HIV.
- Patient with metastatic malignancy.
- Patient with previous liver transplantation
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- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient use oriental medicine within the previous 2 weeks.
- 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
Official title: An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B Associated Hepatocellular Carcinoma
An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma
- Being tested
- clevudine, Adefovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clevudine, AdefovirDrug
Nucleoside-analogue naive patient : Clevudine 30mg qd
- Assess the complete virological response(HBV DNA < 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd
- Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd
- During medication of Clevudine, virological breakthrough : add adefovir 10mg qd
- During treatment period, composite virological response : stop the medication and F/U for 2 years
- Recurrence after stopping treatment(HBV DNA > 2,000IU/ml) retreat medication at composite virological response.
- complete virological response: HBV DNA < 60 IU/ml
- virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBV DNA levels < 60 IU/mL
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Associated Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263002
- Sponsor's protocol ID
- CLV-413
- Status last verified
- Dec 2014
- First submitted
- 17 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
- An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B Associated Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01263002
- Acronym / sponsor ID
- CLV-413
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 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.
An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with chronic HBV DNA and/or with symptoms of liver cirrhosis
- Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
Key exclusion criteria (11 listed)
- Patient is currently receiving antiviral 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 is coinfected with HCV, HDV or HIV.
- Patient with metastatic malignancy.
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, AdefovirNucleoside-analogue naive patient : Clevudine 30mg qd 1. Assess the complete virological response(HBV DNA < 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd 2. Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd 3. During medication of Clevudine, virological breakthrough : add adefovir 10mg qd 4. During treatment period, composite virological response : stop the medication and F/U for 2 years 5. Recurrence after stopping treatment(HBV DNA > 2,000IU/ml) retreat medication at composite virological response. * complete virological response: HBV DNA < 60 IU/ml * virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously. | Drug | – |
Primary outcome
Proportion of patients with HBV DNA levels < 60 IU/mL
Time frame: 48 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 Hepatitis B Associated Hepatocellular Carcinoma
Not yet recruitingObservational study
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)
Hepatocellular Carcinoma, Liver Cirrhosis
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, Adefovir in people with Hepatitis B Associated Hepatocellular Carcinoma, 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 12 inclusion and 11 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 < 60 IU/mL (time frame: 48 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.