To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis BPhase 2NCT05256823
Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B
A Phase 2 study testing Celecoxib and nucleos(t)ide analogue in people with To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis B, run by Lai Wei at 4 sites in China.
Trial summary
In the globe, about 33% (2 billion) of population has ever been infected with hepatitis B virus (HBV), and about 5% (350-400 million) were chronical HBV infection. In areas with high prevalence of hepatitis B, up to 80% of primary liver cancers are associated with HBV infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis B
- What is being tested?
- Celecoxib and nucleos(t)ide analogue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesChina
- Study dates
- 24 Feb 2022to 31 Dec 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Aged 18-65;
- Males or females;
- Clinically diagnosed as chronic hepatitis B before taking nucleos(t)ide analogues (Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide Fumarate) (HBsAg and/or positive HBV DNA for over 6 months, consistent or recurrent ALT elevation, histology confirmed chronic hepatitis B);
- AST and ALT≤10 x ULN;
- Total bilirubin ≤2 x ULN;
- Having been treated with nucleos(t)ide analogues (Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide Fumarate) for more than 1 year;
Show all 10Show fewer
- 100IU/ml < HBsAg < 1500IU/ml;
- HBV DNA < 20IU/ml;
- Child-Pugh class A;
- Willing to sign an informed consent form.
Who cannot join
- Patients with known allergy to Celecoxib or Sulfonamide;
- Patients with oral aspirin or other NSAIDS (non-steroidal anti-inflammatory drugs) induced asthma, urticaria or anaphylactic reactions;
- Patients treated for perioperative pains post coronary artery bypass graft (CABG);
- Patients with active gastrointestinal ulcer/hemorrhage;
- Patients with severe heart failure;
- Patients with myocardial infarction within 3 months prior to enrollment;
Show all 19Show fewer
- ALT >10 x ULN or total bilirubin >2 x ULN;
- Patients with peripheral leukocyte and/or platelet counts lower than lower limits of normal (LLN);
- Patients with severe diseases of visceral organs (included but not limited cardiovascular, lung, kidney, brain) and fundus lesions;
- Patients with concurrent autoimmune diseases, psychosis, diabetes, thyroid dysfunction (hyperactivity or hypothyroidism);
- Patients with definite or suspected liver cancer or other malignancies;
- Patients with historically organ transplant or ready to undergo organ transplant;
- Patients on immunosuppressants;
- Female patients who are pregnant or intended to become pregnant within 2 years;
- Patients with history of drug or alcohol abuse;
- Child-Pugh class B or C (current or prior onset);
- Patients with concurrent HIV infection;
- Patients with other liver diseases (including but not limited to positive Hepatitis C antibody);
- Patients who are unable or unwilling to provide informed consent form or comply with study requirement.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Bejing Tsinghua Changgung Hospital
Beijing, Bejing, 100015
Tianjin Third Center Hospital
Tianjin, Tianjin Municipality, 300170
About this study
Official title: A Pilot, Randomized, Open-label, Single Dose Study to Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B(a Multicenter, Open-labelled, Randomized Controlled Trial)
In the globe, about 33% (2 billion) of population has ever been infected with hepatitis B virus (HBV), and about 5% (350-400 million) were chronical HBV infection. In areas with high prevalence of hepatitis B, up to 80% of primary liver cancers are associated with HBV infection. About 25% of chronic hepatitis B virus carrier (more than 1 million people per year) eventually die of end stage liver disease associated with HBV infection, such as liver failure associated with cirrhosis and hepatocellular carcinoma. HBV replicates in the liver, which increases the risk of hepatocellular carcinoma in HBV carriers. Studies have shown that the risk of hepatocellular carcinoma (HCC) in HBV carriers was 10-100 folds higher than that of non-carriers.
Clinically, there are primarily two types of antiviral drugs: α-interferons (plain and pegylated ([PEG-IFN]α-2a or α-2b) interferons) and nucleos(t)ide analogues (NUC) including lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (LDT), tenofovir disoproxil fumarate(TDF) and tenofovir alafenamide fumarate(TAF). With the development and application of antiviral drugs in recent years, the basic goal of maintain suppression against virus replication has been achieved, and HBsAg loss is considered as function cure of antiviral therapy. However, data from clinical studies showed a very low cure rate of current antiviral drugs and a natural HBsAg loss usually is less than 3%. The vast majority of clinical patients require long-term antiviral treatment and have difficulties in treatment stop.
Read more
The AI data mining system innovated by the Holy Haid owns a ten-million-scaled database and utilizes dozens of HBV-associated targets to identify 100 drugs that are most closely to the targets among the 500 commercially available drugs. With the identified 100 drugs, Holy Haid (Ying-ying Li) and Beijing Tsinghua Changgung Hospital (Lai Wei) conducted a cytological verification in mice, which indicated that the HD042 (Celecoxib) at 20uM concentration can inhibit HBV DNA, HBsAg and HBeAg by 70.87%, 88.52% and 87.55% respectively, without significant cytotoxicity. Based on this, Beijing Tsinghua Changgung Hospital (Lai Wei) retrospectively analyzed 1,114,661 patients admitted to 304 hospitals in 107 cities of 21 provinces and municipalities from January 1, 2019 to October 31, 2020 and identified 19,692 patients with the results of two HBsAg tests available and an interval of over 30 days. Among these, 3,359 patients had ever took HD042 (Celecoxib). Further analysis showed that these 3,359 patients, and screened out 383 patients who were diagnosed of hepatitis B and excluded from tumor with two HBsAg levels > 0.05IU/ml but ≤1500IU/ml. Among these, 110 patients were prescribed for more than 5 Celecoxib doses (about 30 days of treatment). Among the 110 patients, we screened out 27 patients on Celecoxib for 12 weeks whose HBsAg expression decreased by 59.2% after 12 weeks, including HBsAg clearance rate (i.e., HBsAg decreased to < 0.05IU/ mL) up to 18.5%.
Celecoxib, a specific inhibitor of Cyclooxygenase 2 (COX-2), has been widely used in clinical practice as an anti-inflammatory and analgesic drug. Studies have shown that Celecoxib improves NASH by inhibiting inflammatory responses. In addition, some studies have also shown that COX-2 is highly expressed in hepatitis B related hepatocellular carcinoma, resulting in cancerous tissue microangiogenesis. Cytological test found that Celecoxib, as a COX-2 specific inhibitor, can inhibit the growth of liver cancer cells by induced apoptosis and cell cycle inhibition, and have a even stronger effect on HBsAg positive liver cancer cells. However, the inhibitory effect of Celecoxib on the hepatitis B surface antigen in patients with chronic hepatitis B remained controversial. Therefore, this study is designed to investigate the safety and efficacy of Celecoxib in the hepatitis B surface antigen loss and reduction in nucleoside-treated patients with chronic hepatitis B.
- Being tested
- Celecoxib, nucleos(t)ide analogue
- Keywords
- Chronic Hepatitis B
- 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.
CelecoxibDrug
Patients will be treated with Celecoxib twice daily for 48 weeks.
nucleos(t)ide analogueDrug
Patients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients will be given a combination of Celecoxib and one nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks Receives: Drug: Celecoxib; Drug: nucleos(t)ide analogue |
| Control group | Other | Patients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks Receives: Drug: nucleos(t)ide analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg loss after treatment for 48 weeks and discontinuation for 24 weeks
HBsAg loss means HBsAg quantification less than 0.05 international unit/milliliter
Measured: treatment for 48 weeks and discontinuation for 24 weeks
The reduction of HBsAg after treatment for 48 weeks and discontinuation for 24 weeks;
The reduction of HBsAg means a decrease in the value
Measured: treatment for 48 weeks and discontinuation for 24 weeks
Secondary outcomes (6)
The rate of HBsAg loss after treatment for 12 weeks,24 weeks,36 weeks,48 weeks
HBsAg loss means HBsAg quantification less than 0.05 international unit/milliliter
Measured: treatment for 12 weeks,24 weeks,36 weeks,48 weeks
The reduction of HBsAg after treatment for 12 weeks,24 weeks,36 weeks,48 weeks
The reduction of HBsAg means a decrease in the value
Measured: treatment for 12 weeks,24 weeks,36 weeks,48 weeks
The rate of HBsAg loss after discontinuation for 12 weeks
HBsAg loss means HBsAg quantification less than 0.05 international unit/milliliter
Measured: discontinuation for 12 weeks
The reduction of HBsAg after discontinuation for 12 weeks
The reduction of HBsAg means a decrease in the value
Measured: discontinuation for 12 weeks
The alanine aminotransferase level changing during treatment.
The alanine aminotransferase level means fluctuations in aminotransferase values
Measured: treatment for 12 weeks, 24 weeks, 36 weeks, 48 weeks, and discontinuation for 12 weeks, 24 weeks
Safety of Celecoxib plus nucleos(t)ide analogues in treating chronic hepatitis B
Safety of Celecoxib plus nucleos(t)ide means the incidence of adverse events
Measured: treatment for 12 weeks, 24 weeks, 36 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start24 Feb 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized block design will be used to randomly randomize the subjects to the test or control group at a rate of 3:1 with 4 as the block length. The SAS software will be used to generate a random number table and assign a unique random number to every subject eligible for screening before the first dose of the investigational product.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lai Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lai Wei, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256823
- Sponsor's protocol ID
- CG-SLXB-001
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data might be available upon request after approval of IRB
Publications
Aghemo A, Lampertico P, Colombo M. Assessing long-term treatment efficacy in chronic hepatitis B and C: between evidence and common sense. J Hepatol. 2012 Dec;57(6):1326-35. doi: 10.1016/j.jhep.2012.06.025. Epub 2012 Jun 28.
PubMed 22750749Cornberg M, Lok AS, Terrault NA, Zoulim F; 2019 EASL-AASLD HBV Treatment Endpoints Conference Faculty. Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conferencedouble dagger. J Hepatol. 2020 Mar;72(3):539-557. doi: 10.1016/j.jhep.2019.11.003. Epub 2019 Nov 12.
PubMed 31730789
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Open-label, Single Dose Study to Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B(a Multicenter, Open-labelled, Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05256823
- Acronym / sponsor ID
- CG-SLXB-001
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Lai WeiUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Feb 2022 (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 globe, about 33% (2 billion) of population has ever been infected with hepatitis B virus (HBV), and about 5% (350-400 million) were chronical HBV infection. In areas with high prevalence of hepatitis B, up to 80% of primary liver cancers are associated with HBV infection. About 25% of chronic hepatitis B virus carrier (more than 1 million people per year) eventually die of end stage liver disease associated with HBV infection, such as liver failure associated with cirrhosis and hepatocellular carcinoma. HBV replicates in the liver, which increases the risk of hepatocellular carcinoma in HBV carriers. Studies have shown that the risk of hepatocellular carcinoma (HCC) in HBV carriers was 10-100 folds higher than that of non-carriers.
Clinically, there are primarily two types of antiviral drugs: α-interferons (plain and pegylated ([PEG-IFN]α-2a or α-2b) interferons) and nucleos(t)ide analogues (NUC) including lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (LDT), tenofovir disoproxil fumarate(TDF) and tenofovir alafenamide fumarate(TAF). With the development and application of antiviral drugs in recent years, the basic goal of maintain suppression against virus replication has been achieved, and HBsAg loss is considered as function cure of antiviral therapy. However, data from clinical studies showed a very low cure rate of current antiviral drugs and a natural HBsAg loss usually is less than 3%. The vast majority of clinical patients require long-term antiviral treatment and have difficulties in treatment stop.
The AI data mining system innovated by the Holy Haid owns a ten-million-scaled database and utilizes dozens of HBV-associated targets to identify 100 drugs that are most closely to the targets among the 500 commercially available drugs. With the identified 100 drugs, Holy Haid (Ying-ying Li) and Beijing Tsinghua Changgung Hospital (Lai Wei) conducted a cytological verification in mice, which indicated that the HD042 (Celecoxib) at 20uM concentration can inhibit HBV DNA, HBsAg and HBeAg by 70.87%, 88.52% and 87.55% respectively, without significant cytotoxicity. Based on this, Beijing Tsinghua Changgung Hospital (Lai Wei) retrospectively analyzed 1,114,661 patients admitted to 304 hospitals in 107 cities of 21 provinces and municipalities from January 1, 2019 to October 31, 2020 and identified 19,692 patients with the results of two HBsAg tests available and an interval of over 30 days. Among these, 3,359 patients had ever took HD042 (Celecoxib). Further analysis showed that these 3,359 patients, and screened out 383 patients who were diagnosed of hepatitis B and excluded from tumor with two HBsAg levels > 0.05IU/ml but ≤1500IU/ml. Among these, 110 patients were prescribed for more than 5 Celecoxib doses (about 30 days of treatment). Among the 110 patients, we screened out 27 patients on Celecoxib for 12 weeks whose HBsAg expression decreased by 59.2% after 12 weeks, including HBsAg clearance rate (i.e., HBsAg decreased to < 0.05IU/ mL) up to 18.5%.
Celecoxib, a specific inhibitor of Cyclooxygenase 2 (COX-2), has been widely used in clinical practice as an anti-inflammatory and analgesic drug. Studies have shown that Celecoxib improves NASH by inhibiting inflammatory responses. In addition, some studies have also shown that COX-2 is highly expressed in hepatitis B related hepatocellular carcinoma, resulting in cancerous tissue microangiogenesis. Cytological test found that Celecoxib, as a COX-2 specific inhibitor, can inhibit the growth of liver cancer cells by induced apoptosis and cell cycle inhibition, and have a even stronger effect on HBsAg positive liver cancer cells. However, the inhibitory effect of Celecoxib on the hepatitis B surface antigen in patients with chronic hepatitis B remained controversial. Therefore, this study is designed to investigate the safety and efficacy of Celecoxib in the hepatitis B surface antigen loss and reduction in nucleoside-treated patients with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized block design will be used to randomly randomize the subjects to the test or control group at a rate of 3:1 with 4 as the block length. The SAS software will be used to generate a random number table and assign a unique random number to every subject eligible for screening before the first dose of the investigational product.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Celecoxib, Drug: nucleos(t)ide analoguePatients will be given a combination of Celecoxib and one nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks |
| Control group | Other | Drug: nucleos(t)ide analoguePatients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-65;
- Males or females;
- Clinically diagnosed as chronic hepatitis B before taking nucleos(t)ide analogues (Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide Fumarate) (HBsAg and/or positive HBV DNA for over 6 months, consistent or recurrent ALT elevation, histology confirmed chronic hepatitis B);
- AST and ALT≤10 x ULN;
- Total bilirubin ≤2 x ULN;
Key exclusion criteria (19 listed)
- Patients with known allergy to Celecoxib or Sulfonamide;
- Patients with oral aspirin or other NSAIDS (non-steroidal anti-inflammatory drugs) induced asthma, urticaria or anaphylactic reactions;
- Patients treated for perioperative pains post coronary artery bypass graft (CABG);
- Patients with active gastrointestinal ulcer/hemorrhage;
- Patients with severe heart failure;
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 |
|---|---|---|
| CelecoxibPatients will be treated with Celecoxib twice daily for 48 weeks. | Drug | Experimental Group |
| nucleos(t)ide analoguePatients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks | Drug | Control group, Experimental Group |
Primary outcome
The rate of HBsAg loss after treatment for 48 weeks and discontinuation for 24 weeks
Time frame: treatment for 48 weeks and discontinuation for 24 weeks
HBsAg loss means HBsAg quantification less than 0.05 international unit/milliliter
The reduction of HBsAg after treatment for 48 weeks and discontinuation for 24 weeks;
Time frame: treatment for 48 weeks and discontinuation for 24 weeks
The reduction of HBsAg means a decrease in the value
6 secondary outcomes
The rate of HBsAg loss after treatment for 12 weeks,24 weeks,36 weeks,48 weeks
Time frame: treatment for 12 weeks,24 weeks,36 weeks,48 weeks
The reduction of HBsAg after treatment for 12 weeks,24 weeks,36 weeks,48 weeks
Time frame: treatment for 12 weeks,24 weeks,36 weeks,48 weeks
The rate of HBsAg loss after discontinuation for 12 weeks
Time frame: discontinuation for 12 weeks
The reduction of HBsAg after discontinuation for 12 weeks
Time frame: discontinuation for 12 weeks
The alanine aminotransferase level changing during treatment.
Time frame: treatment for 12 weeks, 24 weeks, 36 weeks, 48 weeks, and discontinuation for 12 weeks, 24 weeks
Safety of Celecoxib plus nucleos(t)ide analogues in treating chronic hepatitis B
Time frame: treatment for 12 weeks, 24 weeks, 36 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 22750749Aghemo A, Lampertico P, Colombo M. Assessing long-term treatment efficacy in chronic hepatitis B and C: between evidence and common sense. J Hepatol. 2012 Dec;57(6):1326-35. doi: 10.1016/j.jhep.2012.06.025. Epub 2012 Jun 28.
- Background: PubMed 31730789Cornberg M, Lok AS, Terrault NA, Zoulim F; 2019 EASL-AASLD HBV Treatment Endpoints Conference Faculty. Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conferencedouble dagger. J Hepatol. 2020 Mar;72(3):539-557. doi: 10.1016/j.jhep.2019.11.003. Epub 2019 Nov 12.
- Individual participant dataSharing planned: No. Individual participant data might be available upon request after approval of IRB
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and nucleos(t)ide analogue in people with To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis B, run by Lai Wei at 4 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 10 inclusion and 19 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rate of HBsAg loss after treatment for 48 weeks and discontinuation for 24 weeks (time frame: treatment for 48 weeks and discontinuation for 24 weeks). The study lists 2 primary outcomes in all. 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 NCT05256823, which also lists 2 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 3 Aug 2022.