Chronic Hepatitis BPOWERNCT05755776
The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment
An observational study of Chronic Hepatitis B, run by The Second Affiliated Hospital of Chongqing Medical University at 13 sites in China.
Trial summary
The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is: The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia. 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?
- TMF
- How many people
- 204 participants
- Where
- 13 sitesChina
- Study dates
- 1 Mar 2023to Dec 2024
- 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: The target population was chronic hepatitis B patients with LLV (HBV DNA from 20-to 2000IU/mL) of ETV treatment from multiple centers across mainland China.
Who may be able to join
- Must be able to understand and sign a written informed consent, which must be obtained prior to screening.
- Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
- Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
- Subjects treated with ETV over 1 year will be able to be enrolled in the study.
- Subjects with 20 ≤ HBV-DNA < 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
- Must be willing and able to comply with all study requirements.
Who cannot join
- Female patients who are pregnant or breastfeeding or who plan to become pregnant during the study period.
- Men and women of childbearing potential who are unwilling to use an "effective" method of contraception as defined in the protocol during the study period.
- Co-infection with HAV HCV, HIV, HDV or HEV; or co-infection with autologous liver, metabolism-related fatty liver, or drug-induced liver injury.
- Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellular carcinoma)
- Patients who have received a solid organ or bone marrow transplant
- History of malignancy within 5 years prior to screening, except for specific tumors cured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluated for probable malignancy were ineligible.
Show all 13Show fewer
- Currently receiving treatment with immunomodulators (e.g., corticosteroids), investigational drugs, nephrotoxic drugs, or drugs capable of regulating renal excretion. Drugs that modulate renal excretion.
- Renal, cardiovascular, pulmonary, or neurological disease that is considered severe by the investigator.
- Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesis imperfecta, chondromalacia) or multiple fractures.
- Subjects receiving a contraindicated combination drug (subjects receiving a contraindicated drug require a minimum 30-day washout period) and known hypersensitivity reactions to study drugs, metabolites or formulation excipients.
- Current alcohol or drug abuse that, in the investigator's judgment, may interfere with the subject's compliance with study requirements.
- Any other clinical condition that, in the opinion of the investigator, would render the subject unsuitable for the study or unable to comply with the dosing requirements medical condition or prior treatment.
- Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Peng Hu, PhD, +86 13608338064, hp_cq@163.com
- Not yet recruiting
Chongqing University Three Gorges Central Hospital
Chongqing, 400010
Xuan An
- Not yet recruiting
Affiliated Hospital of Guangxi Medical University
Guangxi
Minghua Su
- Not yet recruiting
Hepatobiliary disease of Jilin Province
Jilin City
Hui Chen
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming
Jiawei Geng
- Not yet recruiting
the Second People's Hospital of Yunnan Province
Kunming
Hui Li
- Not yet recruiting
Nanjing Second Hospital
Nanjing
Wei Ye
- Recruiting
The Second Hospital of Ningbo
Ningbo
Airong HU
- Recruiting
Shanghai East Hospital
Shanghai
Lihong QU
- Not yet recruiting
Shuguang Hospital, Shanghai, China.
Shanghai
Xuehua Sun
- Not yet recruiting
The Sixth People's Hospital of Shenyang
Shenyang
Xiaofeng Wu
- Not yet recruiting
The First People's Hospital of Taicang
Taicang
Yonglan Pu
- Not yet recruiting
The Fourth People's Hospital of Zibo
Zibo
Gang Li
About this study
Official title: To Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B (CHB) Patients With Low-level Viraemia (LLV) After Entecavir Treatment
The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:
- The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
- What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.
Read more
Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.
Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.
- Conditions
- Chronic Hepatitis B
- Being tested
- TMF
- Keywords
- Chronic Hepatitis b, Entecavir, Tenofovir Amibufenamide, Low-level viraemia
- 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.
TMFDrug
Also called Heng Mu
switch ETV to TMF
| Study group | Role | What they receive |
|---|---|---|
| ETV group | Participants in this group will continue ETV daily until the end of the study. | |
| TMF group | Participants in this group will switch to TMF 25 mg, daily until the end of the study. Receives: Drug: TMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.
Undetectable HBV DNA is defined as below 20 IU/mL.
Measured: 48 weeks
Secondary outcomes (9)
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24.
Undetectable HBV DNA is defined as below 20 IU/mL.
Measured: 24 weeks
The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48.
There are two criteria for ALT normalization. Criteria1: below 40 U/L. Criteria2: Males: ALT<30U/L, female: ALT<19U/L.
Measured: 24 weeks and 48 weeks
Comparing pgRNA levels from baseline at week 24 and 48.
Measured: 24 weeks and 48 weeks
Comparing HBcrAg levels from baseline at week 24 and 48.
Measured: 24 weeks and 48 weeks
The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48.
Undetectable pgRNA is defined as below 100 pg/mL.
Measured: 24 weeks and 48 weeks
The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48.
Measured: 24 weeks and 48 weeks
Comparing degree of liver fibrosis from baseline at week 24 and 48.
Evaluation of liver fibrosis including Fibroscan, APRI and FIB-4.
Measured: 24 weeks and 48 weeks
Comparing the change of creatinine clearance rate from baseline at week 24 and 48.
Measured: 24 weeks and 48 weeks
The types, incidence and severity of adverse events and serious adverse events during treatment were evaluated in both groups
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Peng Hu, phD, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755776
- Sponsor's protocol ID
- HS-10234-A005
- Acronym
- POWER
- Status last verified
- Oct 2022
- First submitted
- 23 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu 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 16391218Terrault 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 29405329Sun 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 28012257Wang 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 29113914Yuen MF, Seto WK, Fung J, Wong DK, Yuen JC, Lai CL. Three years of continuous entecavir therapy in treatment-naive chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety. Am J Gastroenterol. 2011 Jul;106(7):1264-71. doi: 10.1038/ajg.2011.45. Epub 2011 Mar 1.
PubMed 21364549Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for management of chronic hepatitis B. Clin Mol Hepatol. 2019 Jun;25(2):93-159. doi: 10.3350/cmh.2019.1002. Epub 2019 Jun 12. No abstract available.
PubMed 31185710Ogawa 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 32304611Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.
PubMed 34587302
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B (CHB) Patients With Low-level Viraemia (LLV) After Entecavir Treatment
- ClinicalTrials.gov ID
- NCT05755776
- Acronym / sponsor ID
- POWER / HS-10234-A005
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis b, Entecavir, Tenofovir Amibufenamide, Low-level viraemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Mar 2023 (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 goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:
- The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
- What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.
Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.
Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETV group | – | –Participants in this group will continue ETV daily until the end of the study. |
| TMF group | – | Drug: TMFParticipants in this group will switch to TMF 25 mg, daily until the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population was chronic hepatitis B patients with LLV (HBV DNA from 20-to 2000IU/mL) of ETV treatment from multiple centers across mainland China.
Key inclusion criteria (6 listed)
- Must be able to understand and sign a written informed consent, which must be obtained prior to screening.
- Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
- Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
- Subjects treated with ETV over 1 year will be able to be enrolled in the study.
- Subjects with 20 ≤ HBV-DNA < 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
Key exclusion criteria (13 listed)
- Female patients who are pregnant or breastfeeding or who plan to become pregnant during the study period.
- Men and women of childbearing potential who are unwilling to use an "effective" method of contraception as defined in the protocol during the study period.
- Co-infection with HAV HCV, HIV, HDV or HEV; or co-infection with autologous liver, metabolism-related fatty liver, or drug-induced liver injury.
- Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellular carcinoma)
- Patients who have received a solid organ or bone marrow transplant
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 |
|---|---|---|
| TMFAlso: Heng Muswitch ETV to TMF | Drug | TMF group |
Primary outcome
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.
Time frame: 48 weeks
Undetectable HBV DNA is defined as below 20 IU/mL.
9 secondary outcomes
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24.
Time frame: 24 weeks
The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing pgRNA levels from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing HBcrAg levels from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48.
Time frame: 24 weeks and 48 weeks
The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing degree of liver fibrosis from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing the change of creatinine clearance rate from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
The types, incidence and severity of adverse events and serious adverse events during treatment were evaluated in both groups
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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 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 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 29113914Wang 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.
- Background: PubMed 21364549Yuen MF, Seto WK, Fung J, Wong DK, Yuen JC, Lai CL. Three years of continuous entecavir therapy in treatment-naive chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety. Am J Gastroenterol. 2011 Jul;106(7):1264-71. doi: 10.1038/ajg.2011.45. Epub 2011 Mar 1.
- Background: PubMed 31185710Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for management of chronic hepatitis B. Clin Mol Hepatol. 2019 Jun;25(2):93-159. doi: 10.3350/cmh.2019.1002. Epub 2019 Jun 12. 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 34587302Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.
- Individual participant dataSharing planned: Undecided
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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.
Peng Hu, phD study director
The Second Affiliated Hospital of Chongqing Medical University
13 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 The Second Affiliated Hospital of Chongqing Medical University at 13 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 6 inclusion and 13 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 Jie Wu (+86 18652100702, wuj6@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48. (time frame: 48 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 NCT05755776, which also lists 10 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 21 Sep 2023.