Sustained Virologic ResponseREACHNCT04724785
Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients
An observational study of Sustained Virologic Response and Hepatitis B, Chronic, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Sustained Virologic Response, Hepatitis B, Chronic
- What is being tested?
- only monitoring, monitoring and regimen change if necessary and regimen change
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2022
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The research subjects were patients with CHB (chronic hepatitis B) receiving ETV or second-line NA(LAM/ADV/LdT) who were admitted to The Second Affiliated Hospital of Chongqing Medical University and other centers.
Who may be able to join
- any patients treated with ETV\LAM\ADF\LDT\TDF\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
Who cannot join
- with a expected life span <48 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
DACHUAN CAI, PhD, 862362887039, 597521685@qq.com
PENG HU, PhD, 8613608338064, hp_cq@163.com
About this study
Official title: Real World Study on the Effect of HBV-DNA High-precision Detection Based Anti-viral Regimen Adjustment on Achieving Complete Virologic Response in Patients With Chronic Hepatitis B.(REACH)
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC). In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT). About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible. It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.
Read the detailed description
In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.
All patients with chronic hepatitis B(CHB) receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen so that the actual prevalence of HBV-DNA load < 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.
- Conditions
- Sustained Virologic Response, Hepatitis B, Chronic
- Being tested
- only monitoring, monitoring and regimen change if necessary, regimen change
- 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.
only monitoringOther
monitoring the viraemia only
monitoring and regimen change if necessaryOther
if those patients agree, the regimen will be changed.
regimen changeDrug
Based on ongoing one, regimen will be changed . The principle for adjusting anti-viral regimen is as follows: 1. The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3. TAF or ETV is recommended for patients with one or more TDF risk factors, such as > 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
| Study group | Role | What they receive |
|---|---|---|
| patients with persistant low level HBV DNA (<10 IU/ml) | No further intervention(s) to be administered except for monitoring of HBV DNA viraemia Receives: Other: only monitoring | |
| patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen | All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen. If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea Receives: Other: monitoring and regimen change if necessary | |
| patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen | All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using. Receives: Drug: regimen change |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
Measured: 24 weeks
Secondary outcomes (5)
The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
Measured: 12 weeks, 48 weeks ,96 weeks
he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point
he proportion of patients with normal Alanine transaminase（ALT ）at baseline and at each follow-up time point
Measured: baseline,12 weeks,48 weeks,96 weeks
Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
Measured: baseline,12 weeks,48 weeks,96 weeks
Changes of serum creatinine(SCr）compared with baseline at each follow-up time point.
Changes of serum creatinine(SCr) compared with baseline at each follow-up time point.
Measured: baseline,12 weeks,48 weeks,96 weeks
Changes of bone mass density（BMD) compared with baseline at each follow-up time point.
Changes of bone mass density (BMD) compared with baseline at each follow-up time point.
Measured: baseline,12 weeks,48 weeks,96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Sustained Virologic ResponseStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caidachuan, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- DACHUAN CAI, PhD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724785
- Sponsor's protocol ID
- 2020LCYJ009
- Acronym
- REACH
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui F, Shen L, Li L, Wang H, Wang F, Bi S, Liu J, Zhang G, Wang F, Zheng H, Sun X, Miao N, Yin Z, Feng Z, Liang X, Wang Y. Prevention of Chronic Hepatitis B after 3 Decades of Escalating Vaccination Policy, China. Emerg Infect Dis. 2017 May;23(5):765-772. doi: 10.3201/eid2305.161477.
PubMed 28418296Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019 Mar 1;97(3):230-238. doi: 10.2471/BLT.18.219469. Epub 2019 Jan 28.
PubMed 30992636Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73. doi: 10.1001/jama.295.1.65.
PubMed 16391218Chen JD, Yang HI, Iloeje UH, You SL, Lu SN, Wang LY, Su J, Sun CA, Liaw YF, Chen CJ; Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer in HBV (REVEAL-HBV) Study Group. Carriers of inactive hepatitis B virus are still at risk for hepatocellular carcinoma and liver-related death. Gastroenterology. 2010 May;138(5):1747-54. doi: 10.1053/j.gastro.2010.01.042. Epub 2010 Jan 28.
PubMed 20114048Liu C, Wang L, Xie H, Zhang L, Wang B, Luo C, Wang S, Tang M, Fu Z, Ruan H, Liu Z, Wei L, Yi W, Xie Y. The relationship between serum hepatitis B virus DNA level and liver histology in patients with chronic HBV infection. PLoS One. 2018 Nov 7;13(11):e0206060. doi: 10.1371/journal.pone.0206060. eCollection 2018.
PubMed 30403735Zhang W, Wang X, Wang Y, Zhao X, Duan W, Wang Q, Wu X, Kong Y, Ma H, You H, Ou X, Jia J. Effective viral suppression is necessary to reduce hepatocellular carcinoma development in cirrhotic patients with chronic hepatitis B: Results of a 10-year follow up. Medicine (Baltimore). 2017 Nov;96(44):e8454. doi: 10.1097/MD.0000000000008454.
PubMed 29095292European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
PubMed 28427875Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
PubMed 29405329Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30.
PubMed 32304611Sun Y, Wu X, Zhou J, Meng T, Wang B, Chen S, Liu H, Wang T, Zhao X, Wu S, Kong Y, Ou X, Wee A, Theise ND, Qiu C, Zhang W, Lu F, Jia J, You H. Persistent Low Level of Hepatitis B Virus Promotes Fibrosis Progression During Therapy. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2582-2591.e6. doi: 10.1016/j.cgh.2020.03.001. Epub 2020 Mar 6.
PubMed 32147592Kim JH, Sinn DH, Kang W, Gwak GY, Paik YH, Choi MS, Lee JH, Koh KC, Paik SW. Low-level viremia and the increased risk of hepatocellular carcinoma in patients receiving entecavir treatment. Hepatology. 2017 Aug;66(2):335-343. doi: 10.1002/hep.28916. Epub 2016 Dec 24.
PubMed 28012257Jang JW, Choi JY, Kim YS, Yoo JJ, Woo HY, Choi SK, Jun CH, Lee CH, Sohn JH, Tak WY, Lee YR, Han KH. Effects of Virologic Response to Treatment on Short- and Long-term Outcomes of Patients With Chronic Hepatitis B Virus Infection and Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1954-1963.e3. doi: 10.1016/j.cgh.2018.04.063. Epub 2018 May 9.
PubMed 29753085Wang J, Sheng Q, Ding Y, Chen R, Sun X, Chen X, Dou X, Lu F. HBV RNA virion-like particles produced under nucleos(t)ide analogues treatment are mainly replication-deficient. J Hepatol. 2018 Apr;68(4):847-849. doi: 10.1016/j.jhep.2017.10.030. Epub 2017 Nov 4. No abstract available.
PubMed 29113914Dandri M, Petersen J. Mechanism of Hepatitis B Virus Persistence in Hepatocytes and Its Carcinogenic Potential. Clin Infect Dis. 2016 Jun 1;62 Suppl 4(Suppl 4):S281-8. doi: 10.1093/cid/ciw023.
PubMed 27190317Kim HJ, Cho YK, Jeon WK, Kim BI. Clinical characteristics of patients with chronic hepatitis B who developed genotypic resistance to entecavir: Real-life experience. Clin Mol Hepatol. 2017 Dec;23(4):323-330. doi: 10.3350/cmh.2017.0005. Epub 2017 Sep 5.
PubMed 28870025
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study on the Effect of HBV-DNA High-precision Detection Based Anti-viral Regimen Adjustment on Achieving Complete Virologic Response in Patients With Chronic Hepatitis B.(REACH)
- ClinicalTrials.gov ID
- NCT04724785
- Acronym / sponsor ID
- REACH / 2020LCYJ009
- Conditions
- Sustained Virologic Response, Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jan 2021 (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.
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC). In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT). About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible. It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.
Detailed description
In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.
All patients with chronic hepatitis B(CHB) receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen so that the actual prevalence of HBV-DNA load < 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with persistant low level HBV DNA (<10 IU/ml) | – | Other: only monitoringNo further intervention(s) to be administered except for monitoring of HBV DNA viraemia |
| patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen | – | Other: monitoring and regimen change if necessaryAll patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen. If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea |
| patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen | – | Drug: regimen changeAll patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The research subjects were patients with CHB (chronic hepatitis B) receiving ETV or second-line NA(LAM/ADV/LdT) who were admitted to The Second Affiliated Hospital of Chongqing Medical University and other centers.
Key inclusion criteria (1 listed)
- any patients treated with ETV\LAM\ADF\LDT\TDF\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
Key exclusion criteria (1 listed)
- with a expected life span <48 weeks
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 |
|---|---|---|
| only monitoringmonitoring the viraemia only | Other | patients with persistant low level HBV DNA (<10 IU/ml) |
| monitoring and regimen change if necessaryif those patients agree, the regimen will be changed. | Other | patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen |
| regimen changeBased on ongoing one, regimen will be changed . The principle for adjusting anti-viral regimen is as follows: 1. The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3. TAF or ETV is recommended for patients with one or more TDF risk factors, such as > 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】 | Drug | patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen |
Primary outcome
The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
Time frame: 24 weeks
The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
5 secondary outcomes
The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
Time frame: 12 weeks, 48 weeks ,96 weeks
he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point
Time frame: baseline,12 weeks,48 weeks,96 weeks
Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
Time frame: baseline,12 weeks,48 weeks,96 weeks
Changes of serum creatinine(SCr）compared with baseline at each follow-up time point.
Time frame: baseline,12 weeks,48 weeks,96 weeks
Changes of bone mass density（BMD) compared with baseline at each follow-up time point.
Time frame: baseline,12 weeks,48 weeks,96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 28418296Cui F, Shen L, Li L, Wang H, Wang F, Bi S, Liu J, Zhang G, Wang F, Zheng H, Sun X, Miao N, Yin Z, Feng Z, Liang X, Wang Y. Prevention of Chronic Hepatitis B after 3 Decades of Escalating Vaccination Policy, China. Emerg Infect Dis. 2017 May;23(5):765-772. doi: 10.3201/eid2305.161477.
- Background: PubMed 30992636Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019 Mar 1;97(3):230-238. doi: 10.2471/BLT.18.219469. Epub 2019 Jan 28.
- Background: PubMed 16391218Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73. doi: 10.1001/jama.295.1.65.
- Background: PubMed 20114048Chen JD, Yang HI, Iloeje UH, You SL, Lu SN, Wang LY, Su J, Sun CA, Liaw YF, Chen CJ; Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer in HBV (REVEAL-HBV) Study Group. Carriers of inactive hepatitis B virus are still at risk for hepatocellular carcinoma and liver-related death. Gastroenterology. 2010 May;138(5):1747-54. doi: 10.1053/j.gastro.2010.01.042. Epub 2010 Jan 28.
- Background: PubMed 30403735Liu C, Wang L, Xie H, Zhang L, Wang B, Luo C, Wang S, Tang M, Fu Z, Ruan H, Liu Z, Wei L, Yi W, Xie Y. The relationship between serum hepatitis B virus DNA level and liver histology in patients with chronic HBV infection. PLoS One. 2018 Nov 7;13(11):e0206060. doi: 10.1371/journal.pone.0206060. eCollection 2018.
- Background: PubMed 29095292Zhang W, Wang X, Wang Y, Zhao X, Duan W, Wang Q, Wu X, Kong Y, Ma H, You H, Ou X, Jia J. Effective viral suppression is necessary to reduce hepatocellular carcinoma development in cirrhotic patients with chronic hepatitis B: Results of a 10-year follow up. Medicine (Baltimore). 2017 Nov;96(44):e8454. doi: 10.1097/MD.0000000000008454.
- Background: PubMed 28427875European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
- Background: PubMed 29405329Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
- Background: PubMed 32304611Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30.
- Background: PubMed 32147592Sun Y, Wu X, Zhou J, Meng T, Wang B, Chen S, Liu H, Wang T, Zhao X, Wu S, Kong Y, Ou X, Wee A, Theise ND, Qiu C, Zhang W, Lu F, Jia J, You H. Persistent Low Level of Hepatitis B Virus Promotes Fibrosis Progression During Therapy. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2582-2591.e6. doi: 10.1016/j.cgh.2020.03.001. Epub 2020 Mar 6.
- Background: PubMed 28012257Kim JH, Sinn DH, Kang W, Gwak GY, Paik YH, Choi MS, Lee JH, Koh KC, Paik SW. Low-level viremia and the increased risk of hepatocellular carcinoma in patients receiving entecavir treatment. Hepatology. 2017 Aug;66(2):335-343. doi: 10.1002/hep.28916. Epub 2016 Dec 24.
- Background: PubMed 29753085Jang JW, Choi JY, Kim YS, Yoo JJ, Woo HY, Choi SK, Jun CH, Lee CH, Sohn JH, Tak WY, Lee YR, Han KH. Effects of Virologic Response to Treatment on Short- and Long-term Outcomes of Patients With Chronic Hepatitis B Virus Infection and Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1954-1963.e3. doi: 10.1016/j.cgh.2018.04.063. Epub 2018 May 9.
- 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.
DACHUAN CAI, PhD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
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 Sustained Virologic Response and Hepatitis B, Chronic, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site 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 1 inclusion and 1 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 5 Aug 2021. 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 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 DACHUAN CAI, Ph D (862362887039, 597521685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment. (time frame: 24 weeks). 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 NCT04724785, which also lists 29 linked publications.
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 5 Aug 2021.