Chronic Hepatitis BNCT06966908
Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
An observational study of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 3 sites in China.
Trial summary
Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department. and Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.
- How many people
- 16,300 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HBsAg-positive patients attending non-infectious disease/hepatology departments. PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B
Who may be able to join
- HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.
- Additional inclusion criteria for the PRO sub-study:
- Age ≥ 18 years;
- Treatment-naïve HBV-infected patients;
- Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
- Be able to understand the study content, willing to participate, and sign the informed consent;
- Have the ability to complete questionnaires independently or with assistance.
Who cannot join
- HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
- Chronic HBV patients on regular antiviral treatment.
- Additional exclusion criteria for the PRO sub-study:
- History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
- Pregnant or lactating women;
- Use of pegylated interferon during the study;
- Failure to complete all follow-up visits;
- Other conditions that the investigator deems inappropriate for participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, PhD, +86 13533978874, pliang@mail.sysu.edu.cn
- Completed
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Completed
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
About this study
Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.
Read the detailed description
The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.
For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.
Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.
Building upon this comprehensive management cohort, the project was expanded in 2025 to include a prospective Patient-Reported Outcomes (PRO) sub-study. This sub-study is designed to evaluate the longitudinal impact of antiviral therapy on the Health-Related Quality of Life among treatment-naïve patients with chronic hepatitis B. Utilizing the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL), the study assesses patients across four key dimensions-physical symptoms, emotional symptoms, beliefs, and social stigma-at baseline, 24 weeks, and 48 weeks post-treatment. By integrating PROs into clinical practice, the Hot wave Project goes beyond traditional biological endpoints to understand the challenges and benefits of HBV treatment from the patient's perspective, ultimately fostering a more patient-centered approach to chronic disease management.
- Conditions
- Chronic Hepatitis B
- Being tested
- Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department., Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.
- Keywords
- Chronic Hepatitis B, linkage to care, management, patient reported outcome
- 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.
Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.Other
After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.
Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.Other
Patients with chronic hepatitis B who meet treatment criteria and have not previously received treatment will undergo a routine clinical evaluation in a private setting under the guidance of trained staff and complete the Chronic Hepatitis B Quality of Life (CHBQOL) questionnaire prior to initiating standard antiviral therapy (baseline, Week 0). Subsequently, patients will return for scheduled follow-up visits at Weeks 24 and 48 after treatment initiation. During follow-up visits, physicians will assess liver function and virological suppression. Additionally, the CHBQOL questionnaire will be administered again to evaluate changes in patients' health-related quality of life over time, as well as to monitor medication adherence and adverse events.
| Study group | Role | What they receive |
|---|---|---|
| In-Hospital HBV Linkage-to-Care Cohort | This cohort consists of HBsAg-positive patients identified in non-hepatology and non-infectious disease departments across three participating medical centers from. An estimated 16,000 patients will be included in this prospective management cohort.Participants in this cohort are managed under the multidisciplinary "Hot wave Project 2.0" workflow. Positive HBsAg results are automatically captured by the hospital information system and flagged with cautionary remarks. Full-time project nurses proactively contact these patients via telephone, providing them with patient education materials, a quick medical consultation card, and encouraging them to visit the dedicated "Hepatitis B Health Clinic" within 2 weeks. Receives: Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department. | |
| Antiviral Therapy PRO Cohort | This cohort consists of adult (≥ 18 years), treatment-naïve patients with chronic hepatitis B enrolled from the "Hot wave Project 2.0" management cohort. Eligible patients must meet the indications for antiviral treatment according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B.Participants in this observational cohort will initiate standard-of-care antiviral therapy as prescribed by their physicians. Throughout the study, their Health-Related Quality of Life will be longitudinally assessed using the localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). PRO assessments, alongside routine clinical parameters will be systematically collected at baseline (Week 0), and at 24 weeks and 48 weeks post-treatment. The target enrollment for this cohort is 300 participants. Receives: Other: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral Rate
Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.
Measured: 2 weeks
Changes in Health-Related Quality of Life assessed by the CHBQOL Scale
Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.
Measured: Baseline (Week 0), week 24, and week 48
Secondary outcomes (4)
Antiviral Treatment Rate
Antiviral treatment rate of HBsAg-positive patients in non-infectious disease departments = Number of patients from non-infectious disease departments starting antiviral treatment / Total number of HBsAg-positive patients in non-infectious disease departments.
Measured: 2 weeks
Incremental Cost-Effectiveness Ratio
This measure evaluates the long-term cost-effectiveness and cost-utility of the "Hot wave" in-hospital management strategy. Real-world data collected from this study-specifically the observed HBV linkage-to-care and treatment initiation rates-will be integrated into a validated decision-analytic Markov model. The model will be parameterized with localized epidemiological and demographic data from Guangzhou . By simulating different policy scenarios over a lifetime horizon, the model will predict cumulative costs and health outcomes, including Quality-Adjusted Life Years (QALYs) and the number of averted HBV-related complications . The final outcome will be expressed as the Incremental Cost-Effectiveness Ratio, representing the cost per additional QALY gained compared to the status quo.
Measured: 3 years
Correlation Between HRQoL Changes and Clinical Responses
To evaluate the relationship between the longitudinal changes in CHBQOL scores (Patient-Reported Outcomes) and key clinical efficacy indicators. Specifically, this measure will analyze how achieving virological suppression (undetectable HBV DNA) and biochemical response (ALT normalization) correlates with improvements or declines in patients' Health-Related Quality of Life during the antiviral treatment period.
Measured: Baseline (Week 0), Week 24, and Week 48
Predictive Factors Affecting HRQoL Changes
To analyze the sociodemographic and clinical factors that significantly influence the trajectory of PRO changes in CHB patients undergoing antiviral therapy. Evaluated factors will include, but are not limited to, patient age, gender, baseline liver fibrosis stage (assessed via FibroScan scores or imaging), and the presence of comorbidities. This analysis aims to identify specific patient subgroups that may require additional clinical attention or distinct management strategies to improve their quality of life.
Measured: Baseline (Week 0), Week 24, and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start3 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen UniversityZhongsi Hong, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityFangfang Wei, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966908
- Sponsor's protocol ID
- PL19
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT06966908
- Acronym / sponsor ID
- PL19
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B, linkage to care, management, patient reported outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,300 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2025 (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.
Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.
Detailed description
The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.
For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.
Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.
Building upon this comprehensive management cohort, the project was expanded in 2025 to include a prospective Patient-Reported Outcomes (PRO) sub-study. This sub-study is designed to evaluate the longitudinal impact of antiviral therapy on the Health-Related Quality of Life among treatment-naïve patients with chronic hepatitis B. Utilizing the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL), the study assesses patients across four key dimensions-physical symptoms, emotional symptoms, beliefs, and social stigma-at baseline, 24 weeks, and 48 weeks post-treatment. By integrating PROs into clinical practice, the Hot wave Project goes beyond traditional biological endpoints to understand the challenges and benefits of HBV treatment from the patient's perspective, ultimately fostering a more patient-centered approach to chronic disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Hospital HBV Linkage-to-Care Cohort | – | Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.This cohort consists of HBsAg-positive patients identified in non-hepatology and non-infectious disease departments across three participating medical centers from. An estimated 16,000 patients will be included in this prospective management cohort.Participants in this cohort are managed under the multidisciplinary "Hot wave Project 2.0" workflow. Positive HBsAg results are automatically captured by the hospital information system and flagged with cautionary remarks. Full-time project nurses proactively contact these patients via telephone, providing them with patient education materials, a quick medical consultation card, and encouraging them to visit the dedicated "Hepatitis B Health Clinic" within 2 weeks. |
| Antiviral Therapy PRO Cohort | – | Other: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.This cohort consists of adult (≥ 18 years), treatment-naïve patients with chronic hepatitis B enrolled from the "Hot wave Project 2.0" management cohort. Eligible patients must meet the indications for antiviral treatment according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B.Participants in this observational cohort will initiate standard-of-care antiviral therapy as prescribed by their physicians. Throughout the study, their Health-Related Quality of Life will be longitudinally assessed using the localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). PRO assessments, alongside routine clinical parameters will be systematically collected at baseline (Week 0), and at 24 weeks and 48 weeks post-treatment. The target enrollment for this cohort is 300 participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HBsAg-positive patients attending non-infectious disease/hepatology departments. PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B
Key inclusion criteria (7 listed)
- HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.
- Age ≥ 18 years;
- Treatment-naïve HBV-infected patients;
- Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
- Be able to understand the study content, willing to participate, and sign the informed consent;
Key exclusion criteria (8 listed)
- HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
- Chronic HBV patients on regular antiviral treatment.
- History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
- Pregnant or lactating women;
- Use of pegylated interferon during the study;
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 |
|---|---|---|
| Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans. | Other | In-Hospital HBV Linkage-to-Care Cohort |
| Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.Patients with chronic hepatitis B who meet treatment criteria and have not previously received treatment will undergo a routine clinical evaluation in a private setting under the guidance of trained staff and complete the Chronic Hepatitis B Quality of Life (CHBQOL) questionnaire prior to initiating standard antiviral therapy (baseline, Week 0). Subsequently, patients will return for scheduled follow-up visits at Weeks 24 and 48 after treatment initiation. During follow-up visits, physicians will assess liver function and virological suppression. Additionally, the CHBQOL questionnaire will be administered again to evaluate changes in patients' health-related quality of life over time, as well as to monitor medication adherence and adverse events. | Other | Antiviral Therapy PRO Cohort |
Primary outcome
Referral Rate
Time frame: 2 weeks
Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.
Changes in Health-Related Quality of Life assessed by the CHBQOL Scale
Time frame: Baseline (Week 0), week 24, and week 48
Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.
4 secondary outcomes
Antiviral Treatment Rate
Time frame: 2 weeks
Incremental Cost-Effectiveness Ratio
Time frame: 3 years
Correlation Between HRQoL Changes and Clinical Responses
Time frame: Baseline (Week 0), Week 24, and Week 48
Predictive Factors Affecting HRQoL Changes
Time frame: Baseline (Week 0), Week 24, and Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Liang Peng principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
Zhongsi Hong principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
Fangfang Wei principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
3 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 Third Affiliated Hospital, Sun Yat-Sen University at 3 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Peng (+8613533978874, pliang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral Rate (time frame: 2 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?
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 8 Apr 2026.