Chronic Hepatitis BNCT01264107
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
An observational study of Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Apr 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Who may be able to join
- Patients is currently clevudine treatment.
- Patients with HBV DNA < 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
- 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 pregnant or breast-feeding.
- Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
- Patient, in the opinion of the investigator, unsuitable for the study.
- Showing Muscle-related Symptom who any other evidence.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soon Koo Baik
Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, 220-701
About this study
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
- Conditions
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sustained antiviral activity effect
Measured: at week 48
Secondary outcomes (5)
The change of sAg
Measured: at week 48
Proportion of sAg loss
Measured: at week 48
The change of HBV DNA form the baseline
(log copies/mL)
Measured: at week 48
Proportion of patients with ALT normalization
Measured: at week 48
Proportion of HBeAg loss/seroconversion
Measured: at week 48
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 startApr 2009
- Primary completionJan 2012
- Study completionApr 2012
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264107
- Sponsor's protocol ID
- CLV-409
- Status last verified
- Jul 2012
- First submitted
- 19 Dec 2010
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
- ClinicalTrials.gov ID
- NCT01264107
- Acronym / sponsor ID
- CLV-409
- Conditions
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (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.
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Key inclusion criteria (3 listed)
- Patients is currently clevudine treatment.
- Patients with HBV DNA < 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (5 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patient is pregnant or breast-feeding.
- Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
- Patient, in the opinion of the investigator, unsuitable for the study.
- Showing Muscle-related Symptom who any other evidence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with sustained antiviral activity effect
Time frame: at week 48
5 secondary outcomes
The change of sAg
Time frame: at week 48
Proportion of sAg loss
Time frame: at week 48
The change of HBV DNA form the baseline
Time frame: at week 48
Proportion of patients with ALT normalization
Time frame: at week 48
Proportion of HBeAg loss/seroconversion
Time frame: at week 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 26 Jul 2012.
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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?
An observational study of 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 3 inclusion and 5 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 26 Jul 2012. 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.
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 sustained antiviral activity effect (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 26 Jul 2012.