Chronic Hepatitis B PatientsNCT05991531
Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients
An observational study of Chronic Hepatitis B Patients, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B Patients
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 31 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years and with HBV DNA negative or LLV.
Who may be able to join
- 1.18 years old or above and the gender is not limited;
- 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
- 3. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
- 4. Good compliance and voluntary signing of informed consent.
Who cannot join
- 1. Patients with decompensated cirrhosis;
- 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
- 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
- 4. Patients have active or suspected malignancy or history of malignancy;
- 5. Patients who were identified not appropriate for the study by investigators.
Trial locations and contacts
1 site in 1 country.
Jialing Zhou, Associate research fellow contact
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Hong Ma, Professor, mahongmd@aliyun.com
Jialing Zhou, Associate research fellow, zhoujialing11@126.com
About this study
Official title: Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues
Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).
- Conditions
- Chronic Hepatitis B Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease of HBV RNA from baseline to 48 weeks
The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;
Measured: 2023.8-2025.8
Secondary outcomes (3)
HBV RNA undetectable rate at 48 weeks;
After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;
Measured: 2023.8-2025.8
The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
Measured: 2023.8-2025.8
The association of HBV RNA changes with the liver stiffness;
During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;
Measured: 2023.8-2025.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B PatientsStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991531
- Sponsor's protocol ID
- Serum HBV RNA
- Status last verified
- Jul 2023
- First submitted
- 6 Aug 2023
- Last updated
- 16 Aug 2023
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues
- ClinicalTrials.gov ID
- NCT05991531
- Acronym / sponsor ID
- Serum HBV RNA
- Conditions
- Chronic Hepatitis B Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Aug 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.
Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years and with HBV DNA negative or LLV.
Key inclusion criteria (4 listed)
- 1.18 years old or above and the gender is not limited;
- 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
- 3. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
- 4. Good compliance and voluntary signing of informed consent.
Key exclusion criteria (5 listed)
- 1. Patients with decompensated cirrhosis;
- 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
- 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
- 4. Patients have active or suspected malignancy or history of malignancy;
- 5. Patients who were identified not appropriate for the study by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The decrease of HBV RNA from baseline to 48 weeks
Time frame: 2023.8-2025.8
The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;
3 secondary outcomes
HBV RNA undetectable rate at 48 weeks;
Time frame: 2023.8-2025.8
The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
Time frame: 2023.8-2025.8
The association of HBV RNA changes with the liver stiffness;
Time frame: 2023.8-2025.8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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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.
Jialing Zhou, Associate research fellow contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Patients, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Ma, Profession (010-63138747, mahongmd@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease of HBV RNA from baseline to 48 weeks (time frame: 2023.8-2025.8). 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 16 Aug 2023.