Chronic Hepatitis BNCT02533544
Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B
An observational study of Chronic Hepatitis B, run by Myeong Jun Song at 1 site in South Korea.
Trial summary
This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- tenofovir disoproxil fumarate
- How many people
- 572 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Oct 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary and Tertiary hospital
Who may be able to join
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Adult male and non-pregnant, non-lactating female subjects, 19 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal).
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
- Chronic hepatitis B with the following:
- HBeAg-positive and HBeAb negative at Screening
- Screening HBV DNA ≥ 1x 105 copies/mL
Show all 18Show fewer
- Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
- HBeAg-negative and HBeAb positive at Screening
- Screening HBV DNA ≥ 1x 104 copies/mL
- Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
- Cirrhosis at Screening
- Screening HBV DNA ≥ 1x 104 copies/mL in HBeAg negative or
- Screening HBV DNA ≥ 1x 105 copies/mL in HBeAg positive
- Screening serum ALT level ≥ ×ULN and ≤ 10 ×ULN (by center laboratory range)
- A patient who treating with TDF as a treatment-naïve for Hepatitis B. Treatment naïve subjects defined as no history of antiviral therapy or < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir
- Decompensated liver cirrhosis defined based on a Child-Turcotte-Pugh (CTP) score ≥ 7 (Child B and C) or presence with at least one episode of ascites, jaundice, hepatic encephalopathy or variceal bleeding
- Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit
- Must be willing and able to comply with all study requirements.
Who cannot join
- Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- Co-infection with HCV, HIV
- Evidence of hepatocellular carcinoma (e.g. α-fetoprotein> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- Currently receiving therapy with cytotoxic agent, nephrotoxic agents, or agents capable of modifying renal excretion
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Daejeon St.Mary's Hosptial
Junggu, Daejeon
About this study
Official title: Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B : a Real Life Multicenter Cohort Study in Korea
This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.
- Conditions
- Chronic Hepatitis B
- Being tested
- tenofovir disoproxil fumarate
- Keywords
- tenofovir disoproxil fumarate
- 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.
tenofovir disoproxil fumarateDrug
| Study group | Role | What they receive |
|---|---|---|
| tenofovir disoproxil fumarate monotherapy | a group which treated with tenofovir disoproxil fumarate Receives: Drug: tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
Measured: week 48
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
Measured: Week 96
Secondary outcomes (9)
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits
Measured: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Measured: Week 48 and 96
The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Measured: Week 48 and 96
The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Measured: Week 48 and 96
The change from baseline in the decline of HBV DNA at every visits
The change from baseline in the decline of HBV DNA at every visits
Measured: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of patients showing virological breakthrough at week 48 and 96
The proportion of patients showing virological breakthrough at week 48 and 96.
Virological Breakthrough defined as any increase in serum HBV DNA by >1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result
Measured: Week 48 and 96
The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96
The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96.
Virological Breakthrough defined as any increase in serum HBV DNA by >1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result
Measured: Week 48 and 96
The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96
The proportion of improvement of liver function including Child Score, MELD score at Week 48 and 96
Measured: Week 48 and 96
The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96
The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96
Measured: Week 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myeong Jun Song
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Wonkwang University, Soonchunhyang University Hospital, Chungnam National University Hospital, Konyang University Hospital
- Responsible party
- Sponsor-investigator, Myeong Jun Song, The Catholic University of Korea
- Investigators
- Myeong Jun Song, Ph.D. M.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533544
- Sponsor's protocol ID
- IN-US-174-1805
- Status last verified
- Jan 2019
- First submitted
- 17 Aug 2015
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kwon JH, Song MJ, Jang JW, Bae SH, Choi JY, Yoon SK, Kim HY, Kim CW, Song DS, Chang UI, Yang JM, You CR, Choi SW, Lee HL, Lee SW, Han NI, Nam SW, Kim SG, Kim YS, Kim SH, Lee BS, Lee TH, Cho EY. Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naive Patients with Chronic Hepatitis B in Korea. Dig Dis Sci. 2019 Jul;64(7):2039-2048. doi: 10.1007/s10620-019-05489-7. Epub 2019 Feb 6.
PubMed 30725293
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B : a Real Life Multicenter Cohort Study in Korea
- ClinicalTrials.gov ID
- NCT02533544
- Acronym / sponsor ID
- IN-US-174-1805
- Conditions
- Chronic Hepatitis B
- Keywords
- tenofovir disoproxil fumarate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Myeong Jun SongUniversity, hospital or other
- Collaborators
- Gilead Sciences, Wonkwang University, Soonchunhyang University Hospital, Chungnam National University Hospital, Konyang University Hospital
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 27 Aug 2015 (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-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tenofovir disoproxil fumarate monotherapy | – | Drug: tenofovir disoproxil fumaratea group which treated with tenofovir disoproxil fumarate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary and Tertiary hospital
Key inclusion criteria (18 listed)
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Adult male and non-pregnant, non-lactating female subjects, 19 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal).
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
- Chronic hepatitis B with the following:
- A patient who treating with TDF as a treatment-naïve for Hepatitis B. Treatment naïve subjects defined as no history of antiviral therapy or < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir
Key exclusion criteria (8 listed)
- Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- Co-infection with HCV, HIV
- Evidence of hepatocellular carcinoma (e.g. α-fetoprotein> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
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 |
|---|---|---|
| tenofovir disoproxil fumarate | Drug | tenofovir disoproxil fumarate monotherapy |
Primary outcome
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
Time frame: week 48
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
Time frame: Week 96
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
9 secondary outcomes
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits
Time frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Time frame: Week 48 and 96
The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Time frame: Week 48 and 96
The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Time frame: Week 48 and 96
The change from baseline in the decline of HBV DNA at every visits
Time frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of patients showing virological breakthrough at week 48 and 96
Time frame: Week 48 and 96
The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96
Time frame: Week 48 and 96
The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96
Time frame: Week 48 and 96
The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96
Time frame: Week 48 and 96
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 30 Jan 2019.
- Derived from this study: PubMed 30725293Kwon JH, Song MJ, Jang JW, Bae SH, Choi JY, Yoon SK, Kim HY, Kim CW, Song DS, Chang UI, Yang JM, You CR, Choi SW, Lee HL, Lee SW, Han NI, Nam SW, Kim SG, Kim YS, Kim SH, Lee BS, Lee TH, Cho EY. Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naive Patients with Chronic Hepatitis B in Korea. Dig Dis Sci. 2019 Jul;64(7):2039-2048. doi: 10.1007/s10620-019-05489-7. Epub 2019 Feb 6.
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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.
Myeong Jun Song, Ph.D. M.D. principal investigator
The Catholic University of Korea
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 Myeong Jun Song 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 18 inclusion and 8 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 30 Jan 2019. 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?
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 (time frame: week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533544, which also lists 1 linked publication.
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 30 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.