Chronic Hepatitis bTRUENCT03752658
TAF Real World Study for Universal Effectiveness
An observational study of Chronic Hepatitis b, run by Tongji Hospital at 7 sites in China.
Trial summary
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Tenofovir Alafenamide
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 7 sitesChina
- Study dates
- 25 Jan 2019to 1 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and non-pregnant, non-lactating female patients with HBsAg positive > 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent. Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
Who may be able to join
- Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
- Adult males and nonpregnant, nonlactating females
- Documented evidence of chronic HBV infection previously
- TAF naive
Who cannot join
- Patents who were TAF experienced
- Women who are breastfeeding
- Pregnant females
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
Show all 21Show fewer
- Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
- Abnormal hematological and biochemical parameters, including:
- Albumin < 2.8 mg/ dL
- International normalized ratio (INR) > 2.3 X ULN (unless stable on anticoagulant regimen)
- Total bilirubin > 3 X ULN
- Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Use of investigational agents within 3 months of screening, unless allowed by the sponsor
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Shulan(Hangzhou) hospitai
Hangzhou
Zhe Yu
Zhe Yu
- Recruiting
First Affiliated Hospital of Nanchang University
Nanchang
Xiaoping Wu, Doctor
Xiaoping Wu
- Recruiting
Shanghai public health clinic
Shanghai
Liang Chen
Liang Chen
- Not yet recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Ning, Prof., 862883662391, qning@vip.sina.com
Qin Ning, Doctor
- Not yet recruiting
General Hospital of The Yangtze River Shipping
Wuhan
Lvye Xu
Lvye Xu
- Recruiting
The Seventh Hospital of Wuhan
Wuhan
Youqin Yan
Youqin Yan
- Recruiting
Xiangya Hospital of Central South University
Xiangya
Yan Huang
Yan Huang
About this study
Official title: A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Read the detailed description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
- Conditions
- Chronic Hepatitis b
- Being tested
- Tenofovir Alafenamide
- 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
Also called Vemlidy®
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir alafenamide (TAF) | Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents. Receives: Drug: Tenofovir Alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of participants with HBV DNA < 20 IU/mL
proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
Measured: 36 months
Secondary outcomes (12)
The proportion of patients with HBV DNA < 20 IU/mL
The proportion of patients with HBV DNA < 20 IU/mL at 12 months
Measured: 12 months
The proportion of patients with HBV DNA <300 copies/mL
The proportion of patients with HBV DNA <300 copies/mL at 12 months
Measured: 12 months
The proportion of patients with HBV DNA < 20 IU/mL
The proportion of patients with HBV DNA < 20 IU/mL at 24 months
Measured: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
The proportion of patients with HBV DNA <300 copies/mL at 24 months
Measured: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
The proportion of patients with HBV DNA <300 copies/mL at 36 months
Measured: 36 months
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months
Measured: 36 months
Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months
Measured: 36 months
Proportion of participants with Normal Alanine Aminotransferase (ALT)
Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months
Measured: 36 months
Change from baseline in fibrosis as assessed by Fibroscan®
Change from baseline in fibrosis as assessed by Fibroscan® at 36 months
Measured: 36 months
Percent Change from baseline in Bone Mineral Density (BMD)
Percent Change from baseline in Bone Mineral Density (BMD) at 36 months
Measured: 36 months
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months
Measured: 36 months
the rate of mother-to-child transmission of HBV
For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate
Measured: at postpartum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start25 Jan 2019
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, MD., Ph.D., Study chair, Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752658
- Sponsor's protocol ID
- IN-US-320-4669
- Acronym
- TRUE
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
- ClinicalTrials.gov ID
- NCT03752658
- Acronym / sponsor ID
- TRUE / IN-US-320-4669
- Conditions
- Chronic Hepatitis b
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 26 Nov 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.
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Detailed description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenofovir alafenamide (TAF) | – | Drug: Tenofovir AlafenamideMale or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and non-pregnant, non-lactating female patients with HBsAg positive > 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent. Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
Key inclusion criteria (4 listed)
- Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
- Adult males and nonpregnant, nonlactating females
- Documented evidence of chronic HBV infection previously
- TAF naive
Key exclusion criteria (21 listed)
- Patents who were TAF experienced
- Women who are breastfeeding
- Pregnant females
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
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 AlafenamideAlso: Vemlidy®The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents | Drug | Tenofovir alafenamide (TAF) |
Primary outcome
proportion of participants with HBV DNA < 20 IU/mL
Time frame: 36 months
proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
12 secondary outcomes
The proportion of patients with HBV DNA < 20 IU/mL
Time frame: 12 months
The proportion of patients with HBV DNA <300 copies/mL
Time frame: 12 months
The proportion of patients with HBV DNA < 20 IU/mL
Time frame: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
Time frame: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
Time frame: 36 months
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
Time frame: 36 months
Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
Time frame: 36 months
Proportion of participants with Normal Alanine Aminotransferase (ALT)
Time frame: 36 months
Change from baseline in fibrosis as assessed by Fibroscan®
Time frame: 36 months
Percent Change from baseline in Bone Mineral Density (BMD)
Time frame: 36 months
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Time frame: 36 months
the rate of mother-to-child transmission of HBV
Time frame: at postpartum 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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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.
Qin Ning, MD., Ph.D. study chair
Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
7 sites 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 Tongji Hospital at 7 sites in China.
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 4 inclusion and 21 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 Qin Ning, MD., Ph.D. (+86 278366 2391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of participants with HBV DNA < 20 IU/mL (time frame: 36 months). 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 Nov 2019.