Chronic Hepatitis bGATENCT04980664
Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
A study testing Integrated intervention strategies in people with Chronic Hepatitis b, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 4 sites in China.
Trial summary
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Integrated intervention strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 4 sitesChina
- Study dates
- Jul 2021to 31 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive HBV surface antigen (HBsAg) for 6 months or more;
- Elevated ALT levels (>1×ULN) and detectable HBV DNA;
- Treatment-naïve;
- Willing to attend this study and able to provide the written informed consent.
Who cannot join
- Co-infection with other viral hepatitis and human immunodeficiency virus;
- Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
- Patients with liver cirrhosis;
- Coexistence of hepatocellular carcinoma and other malignant tumor;
- Underwent liver transplantation before the enrollment;
- Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The Third People's Hospital of Changzhou
Changzhou, Jiangsu, 213001
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, 223300
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
The Affiliated Infectious Diseases Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.
- Conditions
- Chronic Hepatitis b
- Being tested
- Integrated intervention strategies
- Keywords
- Chronic Hepatitis b, Antiviral treatment
- 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.
Integrated intervention strategiesOther
Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.
| Study group | Role | What they receive |
|---|---|---|
| Integrated intervention strategies | Experimental | Not described Receives: Other: Integrated intervention strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of indicated-but-not-treated CHB patients.
The proportion of indicated-but-not-treated CHB patients.
Measured: 18 months
Secondary outcomes (2)
The proportion of lost to follow-up in CHB patients.
Measured: 18 months
The frequency of follow-up visit in CHB patients.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study startJul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980664
- Sponsor's protocol ID
- IN-CN-320-6104
- Acronym
- GATE
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
- ClinicalTrials.gov ID
- NCT04980664
- Acronym / sponsor ID
- GATE / IN-CN-320-6104
- Conditions
- Chronic Hepatitis b
- Keywords
- Chronic Hepatitis b, Antiviral treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated intervention strategies | Experimental | Other: Integrated intervention strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive HBV surface antigen (HBsAg) for 6 months or more;
- Elevated ALT levels (>1×ULN) and detectable HBV DNA;
- Treatment-naïve;
- Willing to attend this study and able to provide the written informed consent.
Key exclusion criteria (6 listed)
- Co-infection with other viral hepatitis and human immunodeficiency virus;
- Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
- Patients with liver cirrhosis;
- Coexistence of hepatocellular carcinoma and other malignant tumor;
- Underwent liver transplantation before the enrollment;
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 |
|---|---|---|
| Integrated intervention strategiesImplementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients. | Other | Integrated intervention strategies |
Primary outcome
The proportion of indicated-but-not-treated CHB patients.
Time frame: 18 months
The proportion of indicated-but-not-treated CHB patients.
2 secondary outcomes
The proportion of lost to follow-up in CHB patients.
Time frame: 18 months
The frequency of follow-up visit in CHB patients.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated intervention strategies in people with Chronic Hepatitis b, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 inclusion and 6 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 28 Jul 2021. 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.
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 Rui Huang, M.D., Ph.D (+86-25-83106666 ext. 20201, doctor_hr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of indicated-but-not-treated CHB patients. (time frame: 18 months). 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 28 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.