Chronic Hepatitis bNCT03559790
Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea
An observational study of Chronic Hepatitis b, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. 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?
- tenofovir alafenamide
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2018to Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population that receive TDF-TAF switch therapy
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, 18 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)
- Previous TDF naïve treatment (more than 96 weeks) baseline status including chronic hepatitis B with the following:
- HBeAg-positive and HBeAb negative at Screening
- Screening HBV DNA ≥ 1x 105 copies/mL
Show all 16Show fewer
- Screening serum ALT level ≥2×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 ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
- Cirrhosis at Screening
- Screening HBV DNA ≥ 1x 104 copies/mL regardless of HBeAg status
- 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
- The decision is made by the provider and patient to switch from TDF to TAF prior to discussion of the study of enrollment
- Following the decision to switch therapy, signed written informed consent after being instructed about the objective and procedure of the clinical study
- 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, 1 recruiting
- Recruiting
The Catholic University of Korea, Daejeon St.Mary's Hosptial
Junggu, Daejeon
Myeong Jun Song, 8242-220-9291
About this study
Official title: Treatment Efficacy and Safety of Tenofovir Alafenamide (TAF) Switch Therapy in Patients Who Have Been Treated With Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B: a Real Life Multicenter Cohort Study in Korea
Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc.
However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B.
The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.
- Conditions
- Chronic Hepatitis b
- Being tested
- tenofovir alafenamide
- Keywords
- chronic hepatitis B, tenofovir alafenamide, tenofovir disoproxil fumarate, Safety, Efficacy
- 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 alafenamideDrug
To evaluate of efficacy and safety in patients with TDF-TAF switch therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Virological response
Portion of subjects with plasma HBV DNA levels below 116 copies/mL
Measured: at Week 96.
Incidence of of elevation of serum creatinine as a measure of renal safety
Incidence of elevation of serum creatinine (>0.5mg/dL) from baseline creatinine
Measured: at Week 96
Incidence of osteopenia and osteoporosis as a measure of bone safety
Incidence of osteopenia and osteoporosis according to Bone Mineral Density
Measured: at Week 96
Secondary outcomes (4)
Biochemical response
ALT normalization (Male <30 IU/L, Female <19 IU/L)
Measured: at Week 48 and 96
Serologic response
loss rate of HBeAg in HBeAg positive patients
Measured: at Week 48 and 96
Serologic response
seroconversion rate in HBeAg positive patients
Measured: at Week 48 and 96
Incidence of treatment-emergent adverse events
all adverse events during tenofovir treatment
Measured: at 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 posted18 Jun 2018
- Study start18 Jul 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myeong Jun Song, The Catholic University of Korea
- Investigators
- Myeong Jun Song, Principal investigator, Daejeon St. Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559790
- Sponsor's protocol ID
- Gilead IN-US-320-4407
- Status last verified
- Jan 2019
- First submitted
- 14 May 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Alafenamide (TAF) Switch Therapy in Patients Who Have Been Treated With Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B: a Real Life Multicenter Cohort Study in Korea
- ClinicalTrials.gov ID
- NCT03559790
- Acronym / sponsor ID
- Gilead IN-US-320-4407
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis B, tenofovir alafenamide, tenofovir disoproxil fumarate, Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 18 Jun 2018 (actual)
- 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.
Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc.
However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B.
The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population that receive TDF-TAF switch therapy
Key inclusion criteria (16 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, 18 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)
- Previous TDF naïve treatment (more than 96 weeks) baseline status including chronic hepatitis B with the following:
- The decision is made by the provider and patient to switch from TDF to TAF prior to discussion of the study of enrollment
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 alafenamideTo evaluate of efficacy and safety in patients with TDF-TAF switch therapy | Drug | – |
Primary outcome
Complete Virological response
Time frame: at Week 96.
Portion of subjects with plasma HBV DNA levels below 116 copies/mL
Incidence of of elevation of serum creatinine as a measure of renal safety
Time frame: at Week 96
Incidence of elevation of serum creatinine (>0.5mg/dL) from baseline creatinine
Incidence of osteopenia and osteoporosis as a measure of bone safety
Time frame: at Week 96
Incidence of osteopenia and osteoporosis according to Bone Mineral Density
4 secondary outcomes
Biochemical response
Time frame: at Week 48 and 96
Serologic response
Time frame: at Week 48 and 96
Serologic response
Time frame: at Week 48 and 96
Incidence of treatment-emergent adverse events
Time frame: at Week 48 and 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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 principal investigator
Daejeon St. Mary's hospital
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 The Catholic University of Korea 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 16 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myeong Jun Song, Ph D (0422209291, mjsong95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Virological response (time frame: at Week 96.). The study lists 3 primary outcomes in all. 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 30 Jan 2019.