Chronic Hepatitis BNCT01776814
Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea
An observational study of Chronic Hepatitis B, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Feb 2013
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in Korea
Who may be able to join
- 18 < Age < 70
- HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
- HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)
Who cannot join
- With HCV or other liver disease
- With kidney disease
- decompensated liver cirrhosis
- with hepatocellular carcinoma
- refuse this clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gachon University Gil Medical Center, Department of Gastroenterology
Incheon, 405-760
Ju Seung Kim, Fellow, +82 +32 460 2792, joojoomj@gilhospital.com
About this study
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.
- Conditions
- Chronic Hepatitis B
- Keywords
- Entecair, Tenofovir
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
virologic response
Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir
Measured: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir
Secondary outcomes (1)
reduction of alanine transaminase
Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir
Measured: changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seung Kim, MD, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776814
- Sponsor's protocol ID
- GAIRB2963-2012
- Status last verified
- Jan 2013
- First submitted
- 18 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea
- ClinicalTrials.gov ID
- NCT01776814
- Acronym / sponsor ID
- GAIRB2963-2012
- Conditions
- Chronic Hepatitis B
- Keywords
- Entecair, Tenofovir
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (estimated)
- First posted
- 28 Jan 2013 (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.
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in Korea
Key inclusion criteria (3 listed)
- 18 < Age < 70
- HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
- HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)
Key exclusion criteria (5 listed)
- With HCV or other liver disease
- With kidney disease
- decompensated liver cirrhosis
- with hepatocellular carcinoma
- refuse this clinical trials
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
virologic response
Time frame: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir
Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir
1 secondary outcome
reduction of alanine transaminase
Time frame: changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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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.
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 Gachon University Gil Medical Center 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: status not confirmed, as of the sponsor's last update on 28 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Seung Kim, Fellow (+80+32 460 2792, joojoomj@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virologic response (time frame: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir). 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 28 Jan 2013.