Chronic HBV InfectionNCT03909191
Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
An observational study of Chronic HBV Infection and Drug Withdrawal, run by Changhai Hospital.
Trial summary
As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic HBV Infection, Drug Withdrawal
- What is being tested?
- serum HBV RNA
- How many people
- 454 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 May 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment
Who may be able to join
- 18 to 70 years old,
- no gender restriction,
- serum HBsAg positive than 6 months,
- can understand and sign informed consent,
- good compliance.
Who cannot join
- coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc;
- coinfected with HIV,
- markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive,
- with hepatocellular carcinoma(HCC)
- with uncontrollable extrehepatic disease,
- received glucocorticoid or other immune inhibitor therapy,
- pregnancy.
About this study
Official title: Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment
As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.
- Conditions
- Chronic HBV Infection, Drug Withdrawal
- Being tested
- serum HBV RNA
- Keywords
- HBV RNA, HBsAg, cccDNA, Nucleos(t)ide analogue, virological relapse
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum HBV RNADiagnostic test
serum HBV RNA level was determined by using HBV-SAT kit at different time point
| Study group | Role | What they receive |
|---|---|---|
| treatment-naïve | treatment-naïve patients with chronic HBV infection Receives: Diagnostic Test: serum HBV RNA | |
| NAs treated CHB patients | CHB patients undergoing long-term NAs treatment Receives: Diagnostic Test: serum HBV RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT
serum HBV RNA level in patients with chronic HBV infection during different natural history stage were were compared. The relationship between serum HBV RNA and other viral markers,such as HBV DNA,HBeAg and HBsAg, were determined.
Measured: serum HBV RNA level were measured 24hs after the enrollment
End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound
End of treatment serum HBV RNA in patients after long-term nucleos(t)ide analog therapy were tested and the predictive effect of EOT HBV RNA value on 24-month off-therapy viral rebound were determined.
Measured: Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined
Secondary outcomes (2)
serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point
serum HBV RNA change pattern along long-term NAs therapy wad determined and the relationship between HBV RNA and HBV DNA or HBsAg during NAs therapy were also determined
Measured: 48 hrs after enrollment the serun HBV RNA level were tested
Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy
the cumulative viral relapse rates at the 1st and 2nd year off-therapy were calculated
Measured: viral rebound rates were calculated from stopping baseline to 24 month after drug cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Feb 2016
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- More trials run by Changhai 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
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiangXS, Changhai Hospital
- Investigators
- Xuesong Liang, Dr, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909191
- Sponsor's protocol ID
- HBV RNA2016
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment
- ClinicalTrials.gov ID
- NCT03909191
- Acronym / sponsor ID
- HBV RNA2016
- Conditions
- Chronic HBV Infection, Drug Withdrawal
- Keywords
- HBV RNA, HBsAg, cccDNA, Nucleos(t)ide analogue, virological relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 9 Apr 2019 (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.
As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment-naïve | – | Diagnostic Test: serum HBV RNAtreatment-naïve patients with chronic HBV infection |
| NAs treated CHB patients | – | Diagnostic Test: serum HBV RNACHB patients undergoing long-term NAs treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment
Key inclusion criteria (5 listed)
- 18 to 70 years old,
- no gender restriction,
- serum HBsAg positive than 6 months,
- can understand and sign informed consent,
- good compliance.
Key exclusion criteria (7 listed)
- coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc;
- coinfected with HIV,
- markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive,
- with hepatocellular carcinoma(HCC)
- with uncontrollable extrehepatic disease,
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 |
|---|---|---|
| serum HBV RNAserum HBV RNA level was determined by using HBV-SAT kit at different time point | Diagnostic test | NAs treated CHB patients, treatment-naïve |
Primary outcome
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT
Time frame: serum HBV RNA level were measured 24hs after the enrollment
serum HBV RNA level in patients with chronic HBV infection during different natural history stage were were compared. The relationship between serum HBV RNA and other viral markers,such as HBV DNA,HBeAg and HBsAg, were determined.
End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound
Time frame: Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined
End of treatment serum HBV RNA in patients after long-term nucleos(t)ide analog therapy were tested and the predictive effect of EOT HBV RNA value on 24-month off-therapy viral rebound were determined.
2 secondary outcomes
serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point
Time frame: 48 hrs after enrollment the serun HBV RNA level were tested
Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy
Time frame: viral rebound rates were calculated from stopping baseline to 24 month after drug cessation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Xuesong Liang, Dr principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic HBV Infection and Drug Withdrawal, run by Changhai Hospital.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT (time frame: serum HBV RNA level were measured 24hs after the enrollment). 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 2 Feb 2021.