Hepatitis B, ChronicNCT04160897
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
An observational study of Hepatitis B, Chronic and Hepatocellular Carcinoma, run by Qing XIe at 1 site in China.
Trial summary
The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis B, Chronic, Hepatocellular Carcinoma, Compensated Cirrhosis
- What is being tested?
- Entecavir and Tenofovir Disoproxil
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2019to 31 Oct 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was conducted in high-risk populations of HCC (patients with cirrhosis). According to the studies from Taiwan and Hongkong, the cumulative incidence of HCC in Chinese patients with cirrhosis in the ETV group was about 11.8-13.8% over 5 years, and we estimate it to be 12.8%; the 5-year incidence of HCC in the TDF group is estimated to be 8.0% according to the studies from Korea with the HR=0.55-0.75. Actual patients' use of ETV and TDF in China is about 3:1. We calculated that for this study to have 80% power to detect a 5% relative difference between the TDF and ETV groups, there would have to be 202 events and enroll 539 and 1616 patients at least in TDF and ETV treatment group based on log-rank (Lakatos) test. On the basis of these calculations, we planned to enroll 4,000 patients (1,000 patients in the TDF group, 3,000 patients in the ETV group).
Who may be able to join
- HBsAg+ > 6 months
- age 18-80
- TDF or ETV Treatment Naive
- cirrhosis
Who cannot join
- TDF/ETV treatment duration<12 m
- decompensated cirrhosis
- previous H/O organ or stem cell transplant
- IFN exposure or combination of IFN>4 w
- HCC, death or OLT within 12 m after TDF or ETV treatment;
- previous HCC history;
- key data (such as key medical history, hematological and biochemical tests, HBV DNA and HBV antibody/antigen before treatment, et al) missing or error.
Trial locations and contacts
1 site in 1 country.
China1 site
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis: A Multicenter, Real-world and Respective Study
The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF. This study is based on a real-world clinical cohort to retrospectively analyze the effects of ETV and TDF on the long-term (5-year) incidence of HCC in Chinese patients with chronic hepatitis B with compensated cirrhosis. The results will guide the revision of the Chinese HBV guidelines.
Read the detailed description
HBV infection is a global problem, and China has a heavy disease burden with approximately 86 million people infected with HBV. According to the epidemiological survey of nearly 230,000 people in Northeast China in 2010-2013, the positive rate of HBsAg reached 6.1%, of which 10.7% had cirrhosis.
According to the latest authoritative guidelines, including the guidelines published in 2018 by American Association for the Study of Liver Diseases (AASLD) and in 2017 by European Association for the Study of Liver Diseases (EASL), entecavir (ETV) and tenofovir diisopropyl (TDF) are recommended as first-line antiviral drugs. ETV is a guanosine nucleoside analog that inhibits HBV polymerase and inhibits the synthesis of HBV DNA. TDF is a cyclic nucleoside phosphorylated diester structural analog of adenosine monophosphate, and its hydrolysis and phosphorylation products can inhibit the activity of HBV reverse transcriptase and also inhibit the synthesis of HBV DNA. In 2005, ETV was listed in China Mainland and TDF was listed in 2014. Over the years, clinical studies have shown that both have good antiviral effects and low drug resistance rates, so they are chosen as first-line antiviral drugs.
HBV infection is one of the risk factors for hepatocellular carcinoma (HCC). Previous studies based on the Chinese patients have shown that antiviral therapy (such as ETV) can significantly reduce the incidence of HCC in patients with cirrhosis (the 4-year cumulative incidence of HCC decreased from 17.5% to 9.4%). However, a study from South Korea published online in September 2018 in JAMA Oncology showed that TDF significantly reduced the incidence of HCC compared to ETV (HR 0.68, 95% CI 0.46-0.99) . In contrast, another multicenter study in Korea, published in March 2019 in The JOURNAL OF HEPATOLOGY showed no significant difference between ETV and TDF (HR 0.975, p=0.852) [4]. In the latter study, there was a problem with the small sample size, and the sample size was not sufficient to test the difference between the two antiviral drugs, and the sample size needed to be expanded to verify the result.
Compared with Koreans, the incidence of HCC in Chinese is significantly lower (in patients with cirrhosis, the 5-year cumulative incidence of HCC is about: China vs Korea: 12% vs 20%), showing the differences between countries. There is at present no similar study based on Chinese patients, especially in patients with cirrhosis to compare the effects of ETV and TDF on the incidence of HCC.
China has a huge disease burden and a high incidence of HCC. The ETV and TDF both have generic drugs marketing in China Mainland which through quality consistency evaluation and entering the 4+7 drug procurement (the centralized drug procurement in "4+7 Cities": Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xian), bringing good antiviral effect to patients at preferential prices. If we can detect the difference in the occurrence of HCC between ETV and TDF, rational selection of drugs will reduce the incidence of HCC in Chinese patients with chronic hepatitis B (Korean studies showed that cumulative HCC patients can reduce 32% in 5 years), greatly reducing the burden on Chinese patients and health care.
This research is a real-world, multi-center, retrospective, and observational study.
Patient data are collected from 5-10 research centers in mainland China, including basic demographic information, antiviral regimen, time of stating antivirus, endpoint event, time of endpoint event, last follow-up time, important testing data, etc.
Patients with the time of last follow-up (or the time of the endpoint event) between 2013-1-1 and 2019-12-31 are included in this study.
Based on the data we collect, the Propensity Score Matching and Inverse Probability Multiple Weighted methods and the Competing Risk Model are utilized to correct the confounding factors to calculate the impact of TDF and ETV on HCC events.
- Being tested
- Entecavir, Tenofovir Disoproxil
- Keywords
- chronic hepatitis B, hepatocellular carcinoma, compensated cirrhosis, Chinese, entecavir, tenofovir disopropyl, multi-center, real-world, respective
- Medical subject headings
- Hepatitis B, Chronic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
entecavir naive for chronic hepatitis B patients
Tenofovir DisoproxilDrug
tenofovir disopropyl naive for chronic hepatitis B patients
| Study group | Role | What they receive |
|---|---|---|
| ETV cohort | CHB patients with entecavir naive treatment Receives: Drug: Entecavir | |
| TDF cohort | CHB patients with naive tenofovir disopropyl naive treatment Receives: Drug: Tenofovir Disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 5-year cumulative incidence of hepatocellular carcinoma
Compare the difference in the 5-year cumulative incidence of HCC in Chinese patients with chronic hepatitis B with cirrhosis in real world between ETV and TDF.
Measured: 5 years
Secondary outcomes (3)
The 5-year cumulative all-cause mortality rate
Compare the difference in the 5-year cumulative all-cause mortality rate in Chinese patients with chronic hepatitis B with cirrhosis in real world between ETV and TDF.
Measured: 5 years
The 5-year cumulative liver transplantation rate
Compare the difference in the 5-year cumulative liver transplantation rate in Chinese patients with chronic hepatitis B with cirrhosis in real world between ETV and TDF.
Measured: 5 years
The 5-year cumulative liver disease-related mortality
Compare the difference in the 5-year cumulative liver disease-related mortality in Chinese patients with chronic hepatitis B with cirrhosis in real world between ETV and TDF.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start22 Oct 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies 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
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing XIe
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai MedSci Healthcare Co. Ltd
- Responsible party
- Sponsor-investigator, Qing XIe, Ruijin Hospital
- Investigators
- Qing Xie, MD, Study chair, Director of Department of Infectious Disease, Rui Jin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160897
- Sponsor's protocol ID
- ISR-CN-9-10708
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Q, Qi W, Wang X, Zhang Y, Xu Y, Qin S, Zhao P, Guo H, Jiao J, Zhou C, Ji S, Wang J. Epidemiology of Hepatitis B and Hepatitis C Infections and Benefits of Programs for Hepatitis Prevention in Northeastern China: A Cross-Sectional Study. Clin Infect Dis. 2016 Feb 1;62(3):305-12. doi: 10.1093/cid/civ859. Epub 2015 Oct 3.
PubMed 26433720Su TH, Hu TH, Chen CY, Huang YH, Chuang WL, Lin CC, Wang CC, Su WW, Chen MY, Peng CY, Chien RN, Huang YW, Wang HY, Lin CL, Yang SS, Chen TM, Mo LR, Hsu SJ, Tseng KC, Hsieh TY, Suk FM, Hu CT, Bair MJ, Liang CC, Lei YC, Tseng TC, Chen CL, Kao JH; C-TEAM study group and the Taiwan Liver Diseases Consortium. Four-year entecavir therapy reduces hepatocellular carcinoma, cirrhotic events and mortality in chronic hepatitis B patients. Liver Int. 2016 Dec;36(12):1755-1764. doi: 10.1111/liv.13253. Epub 2016 Oct 4.
PubMed 27634134Choi J, Kim HJ, Lee J, Cho S, Ko MJ, Lim YS. Risk of Hepatocellular Carcinoma in Patients Treated With Entecavir vs Tenofovir for Chronic Hepatitis B: A Korean Nationwide Cohort Study. JAMA Oncol. 2019 Jan 1;5(1):30-36. doi: 10.1001/jamaoncol.2018.4070.
PubMed 30267080Kim SU, Seo YS, Lee HA, Kim MN, Lee YR, Lee HW, Park JY, Kim DY, Ahn SH, Han KH, Hwang SG, Rim KS, Um SH, Tak WY, Kweon YO, Kim BK, Park SY. A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naive chronic hepatitis B in South Korea. J Hepatol. 2019 Sep;71(3):456-464. doi: 10.1016/j.jhep.2019.03.028. Epub 2019 Apr 6.
PubMed 30959156Wong GL, Chan HL, Mak CW, Lee SK, Ip ZM, Lam AT, Iu HW, Leung JM, Lai JW, Lo AO, Chan HY, Wong VW. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients with liver cirrhosis. Hepatology. 2013 Nov;58(5):1537-47. doi: 10.1002/hep.26301. Epub 2013 Sep 30.
PubMed 23389810Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Infectious Diseases, Chinese Medical Association; Hou JL, lai W. [The guideline of prevention and treatment for chronic hepatitis B: a 2015 update]. Zhonghua Gan Zang Bing Za Zhi. 2015 Dec;23(12):888-905. doi: 10.3760/cma.j.issn.1007-3418.2015.12.002. No abstract available. Chinese.
PubMed 26739464Chinese Foundation for Hepatitis Prevention and Control; Chinese Society of Infectious Disease and Chinese Society of Hepatology, Chinese Medical Association; Liver Disease Committee of Chinese Research Hospital Association. [Consensus on clinical application of transient elastography detecting liver fibrosis: a 2018 update]. Zhonghua Gan Zang Bing Za Zhi. 2019 Mar 20;27(3):182-191. doi: 10.3760/cma.j.issn.1007-3418.2019.03.004. Chinese.
PubMed 30929334
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis: A Multicenter, Real-world and Respective Study
- ClinicalTrials.gov ID
- NCT04160897
- Acronym / sponsor ID
- ISR-CN-9-10708
- Keywords
- chronic hepatitis B, hepatocellular carcinoma, compensated cirrhosis, Chinese, entecavir, tenofovir disopropyl, multi-center, real-world
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Qing XIeUniversity, hospital or other
- Collaborators
- Shanghai MedSci Healthcare Co. Ltd
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 13 Nov 2019 (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.
The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF. This study is based on a real-world clinical cohort to retrospectively analyze the effects of ETV and TDF on the long-term (5-year) incidence of HCC in Chinese patients with chronic hepatitis B with compensated cirrhosis. The results will guide the revision of the Chinese HBV guidelines.
Detailed description
HBV infection is a global problem, and China has a heavy disease burden with approximately 86 million people infected with HBV. According to the epidemiological survey of nearly 230,000 people in Northeast China in 2010-2013, the positive rate of HBsAg reached 6.1%, of which 10.7% had cirrhosis.
According to the latest authoritative guidelines, including the guidelines published in 2018 by American Association for the Study of Liver Diseases (AASLD) and in 2017 by European Association for the Study of Liver Diseases (EASL), entecavir (ETV) and tenofovir diisopropyl (TDF) are recommended as first-line antiviral drugs. ETV is a guanosine nucleoside analog that inhibits HBV polymerase and inhibits the synthesis of HBV DNA. TDF is a cyclic nucleoside phosphorylated diester structural analog of adenosine monophosphate, and its hydrolysis and phosphorylation products can inhibit the activity of HBV reverse transcriptase and also inhibit the synthesis of HBV DNA. In 2005, ETV was listed in China Mainland and TDF was listed in 2014. Over the years, clinical studies have shown that both have good antiviral effects and low drug resistance rates, so they are chosen as first-line antiviral drugs.
HBV infection is one of the risk factors for hepatocellular carcinoma (HCC). Previous studies based on the Chinese patients have shown that antiviral therapy (such as ETV) can significantly reduce the incidence of HCC in patients with cirrhosis (the 4-year cumulative incidence of HCC decreased from 17.5% to 9.4%). However, a study from South Korea published online in September 2018 in JAMA Oncology showed that TDF significantly reduced the incidence of HCC compared to ETV (HR 0.68, 95% CI 0.46-0.99) . In contrast, another multicenter study in Korea, published in March 2019 in The JOURNAL OF HEPATOLOGY showed no significant difference between ETV and TDF (HR 0.975, p=0.852) [4]. In the latter study, there was a problem with the small sample size, and the sample size was not sufficient to test the difference between the two antiviral drugs, and the sample size needed to be expanded to verify the result.
Compared with Koreans, the incidence of HCC in Chinese is significantly lower (in patients with cirrhosis, the 5-year cumulative incidence of HCC is about: China vs Korea: 12% vs 20%), showing the differences between countries. There is at present no similar study based on Chinese patients, especially in patients with cirrhosis to compare the effects of ETV and TDF on the incidence of HCC.
China has a huge disease burden and a high incidence of HCC. The ETV and TDF both have generic drugs marketing in China Mainland which through quality consistency evaluation and entering the 4+7 drug procurement (the centralized drug procurement in "4+7 Cities": Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xian), bringing good antiviral effect to patients at preferential prices. If we can detect the difference in the occurrence of HCC between ETV and TDF, rational selection of drugs will reduce the incidence of HCC in Chinese patients with chronic hepatitis B (Korean studies showed that cumulative HCC patients can reduce 32% in 5 years), greatly reducing the burden on Chinese patients and health care.
This research is a real-world, multi-center, retrospective, and observational study.
Patient data are collected from 5-10 research centers in mainland China, including basic demographic information, antiviral regimen, time of stating antivirus, endpoint event, time of endpoint event, last follow-up time, important testing data, etc.
Patients with the time of last follow-up (or the time of the endpoint event) between 2013-1-1 and 2019-12-31 are included in this study.
Based on the data we collect, the Propensity Score Matching and Inverse Probability Multiple Weighted methods and the Competing Risk Model are utilized to correct the confounding factors to calculate the impact of TDF and ETV on HCC events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETV cohort | – | Drug: EntecavirCHB patients with entecavir naive treatment |
| TDF cohort | – | Drug: Tenofovir DisoproxilCHB patients with naive tenofovir disopropyl naive treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in high-risk populations of HCC (patients with cirrhosis). According to the studies from Taiwan and Hongkong, the cumulative incidence of HCC in Chinese patients with cirrhosis in the ETV group was about 11.8-13.8% over 5 years, and we estimate it to be 12.8%; the 5-year incidence of HCC in the TDF group is estimated to be 8.0% according to the studies from Korea with the HR=0.55-0.75. Actual patients' use of ETV and TDF in China is about 3:1. We calculated that for this study to have 80% power to detect a 5% relative difference between the TDF and ETV groups, there would have to be 202 events and enroll 539 and 1616 patients at least in TDF and ETV treatment group based on log-rank (Lakatos) test. On the basis of these calculations, we planned to enroll 4,000 patients (1,000 patients in the TDF group, 3,000 patients in the ETV group).
Key inclusion criteria (4 listed)
- HBsAg+ > 6 months
- age 18-80
- TDF or ETV Treatment Naive
- cirrhosis
Key exclusion criteria (7 listed)
- TDF/ETV treatment duration<12 m
- decompensated cirrhosis
- previous H/O organ or stem cell transplant
- IFN exposure or combination of IFN>4 w
- HCC, death or OLT within 12 m after TDF or ETV treatment;
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 |
|---|---|---|
| Entecavirentecavir naive for chronic hepatitis B patients | Drug | ETV cohort |
| Tenofovir Disoproxiltenofovir disopropyl naive for chronic hepatitis B patients | Drug | TDF cohort |
Primary outcome
The 5-year cumulative incidence of hepatocellular carcinoma
Time frame: 5 years
Compare the difference in the 5-year cumulative incidence of HCC in Chinese patients with chronic hepatitis B with cirrhosis in real world between ETV and TDF.
3 secondary outcomes
The 5-year cumulative all-cause mortality rate
Time frame: 5 years
The 5-year cumulative liver transplantation rate
Time frame: 5 years
The 5-year cumulative liver disease-related mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 26433720Zhang Q, Qi W, Wang X, Zhang Y, Xu Y, Qin S, Zhao P, Guo H, Jiao J, Zhou C, Ji S, Wang J. Epidemiology of Hepatitis B and Hepatitis C Infections and Benefits of Programs for Hepatitis Prevention in Northeastern China: A Cross-Sectional Study. Clin Infect Dis. 2016 Feb 1;62(3):305-12. doi: 10.1093/cid/civ859. Epub 2015 Oct 3.
- Background: PubMed 27634134Su TH, Hu TH, Chen CY, Huang YH, Chuang WL, Lin CC, Wang CC, Su WW, Chen MY, Peng CY, Chien RN, Huang YW, Wang HY, Lin CL, Yang SS, Chen TM, Mo LR, Hsu SJ, Tseng KC, Hsieh TY, Suk FM, Hu CT, Bair MJ, Liang CC, Lei YC, Tseng TC, Chen CL, Kao JH; C-TEAM study group and the Taiwan Liver Diseases Consortium. Four-year entecavir therapy reduces hepatocellular carcinoma, cirrhotic events and mortality in chronic hepatitis B patients. Liver Int. 2016 Dec;36(12):1755-1764. doi: 10.1111/liv.13253. Epub 2016 Oct 4.
- Background: PubMed 30267080Choi J, Kim HJ, Lee J, Cho S, Ko MJ, Lim YS. Risk of Hepatocellular Carcinoma in Patients Treated With Entecavir vs Tenofovir for Chronic Hepatitis B: A Korean Nationwide Cohort Study. JAMA Oncol. 2019 Jan 1;5(1):30-36. doi: 10.1001/jamaoncol.2018.4070.
- Background: PubMed 30959156Kim SU, Seo YS, Lee HA, Kim MN, Lee YR, Lee HW, Park JY, Kim DY, Ahn SH, Han KH, Hwang SG, Rim KS, Um SH, Tak WY, Kweon YO, Kim BK, Park SY. A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naive chronic hepatitis B in South Korea. J Hepatol. 2019 Sep;71(3):456-464. doi: 10.1016/j.jhep.2019.03.028. Epub 2019 Apr 6.
- Background: PubMed 23389810Wong GL, Chan HL, Mak CW, Lee SK, Ip ZM, Lam AT, Iu HW, Leung JM, Lai JW, Lo AO, Chan HY, Wong VW. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients with liver cirrhosis. Hepatology. 2013 Nov;58(5):1537-47. doi: 10.1002/hep.26301. Epub 2013 Sep 30.
- Background: PubMed 26739464Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Infectious Diseases, Chinese Medical Association; Hou JL, lai W. [The guideline of prevention and treatment for chronic hepatitis B: a 2015 update]. Zhonghua Gan Zang Bing Za Zhi. 2015 Dec;23(12):888-905. doi: 10.3760/cma.j.issn.1007-3418.2015.12.002. No abstract available. Chinese.
- Background: PubMed 30929334Chinese Foundation for Hepatitis Prevention and Control; Chinese Society of Infectious Disease and Chinese Society of Hepatology, Chinese Medical Association; Liver Disease Committee of Chinese Research Hospital Association. [Consensus on clinical application of transient elastography detecting liver fibrosis: a 2018 update]. Zhonghua Gan Zang Bing Za Zhi. 2019 Mar 20;27(3):182-191. doi: 10.3760/cma.j.issn.1007-3418.2019.03.004. Chinese.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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.
Qing Xie, MD study chair
Director of Department of Infectious Disease, Rui Jin 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 Hepatitis B, Chronic and Hepatocellular Carcinoma, run by Qing XIe 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 4 inclusion and 7 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 13 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 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?
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 5-year cumulative incidence of hepatocellular carcinoma (time frame: 5 years). 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 NCT04160897, which also lists 7 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 13 Nov 2019.