HBeAg Positive Chronic Hepatitis B InfectionNCT01480492
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection
A study testing Telbivudine in people with HBeAg Positive Chronic Hepatitis B Infection, run by Cz Li at 1 site in China.
Trial summary
During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have… Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- HBeAg Positive Chronic Hepatitis B Infection
- What is being tested?
- Telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Oct 2011
- 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 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- chronic HBV infection
- HBeAg positive,HBV DNA more than 10E5 IU/mL
- ALT ≥2×UTL
Who cannot join
- with liver cancer
- with liver failure
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study the Effect of Nucleoside on Host Immune in Patients With CHB
During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.
- Being tested
- Telbivudine
- Keywords
- HBV, Immune, antiviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
600mg,1/d,one year
| Study group | Role | What they receive |
|---|---|---|
| therapy | No intervention | Not described Receives: Drug: Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy
Measured: base line-4 weeks-12 weeks-24 weeks-end of therapy
Secondary outcomes (1)
Decline of hepatitis B e antigen (HBeAg) level
Measured: base line-4weeks-12weeks-24weeks-end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HBeAg Positive Chronic Hepatitis B InfectionStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cz Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cz Li, Changhai Hospital
- Investigators
- Wan Mo Bin, Professor, Study director, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480492
- Sponsor's protocol ID
- HBV20111115
- Other IDs
- 09zr400500, 30972600
- Status last verified
- Nov 2011
- First submitted
- 15 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li CZ, Hu JJ, Xue JY, Yin W, Liu YY, Fan WH, Xu H, Liang XS. Viral infection parameters not nucleoside analogue itself correlates with host immunity in nucleoside analogue therapy for chronic hepatitis B. World J Gastroenterol. 2014 Jul 28;20(28):9486-96. doi: 10.3748/wjg.v20.i28.9486.
PubMed 25071343
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Nucleoside on Host Immune in Patients With CHB
- ClinicalTrials.gov ID
- NCT01480492
- Acronym / sponsor ID
- HBV20111115
- Keywords
- HBV, Immune, antiviral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cz LiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Nov 2011 (estimated)
- 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.
During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy | No intervention | Drug: Telbivudine |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- chronic HBV infection
- HBeAg positive,HBV DNA more than 10E5 IU/mL
- ALT ≥2×UTL
Key exclusion criteria (3 listed)
- with liver cancer
- with liver failure
- pregnant
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 |
|---|---|---|
| Telbivudine600mg,1/d,one year | Drug | therapy |
Primary outcome
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy
Time frame: base line-4 weeks-12 weeks-24 weeks-end of therapy
1 secondary outcome
Decline of hepatitis B e antigen (HBeAg) level
Time frame: base line-4weeks-12weeks-24weeks-end of therapy
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 29 Nov 2011.
- Derived from this study: PubMed 25071343Li CZ, Hu JJ, Xue JY, Yin W, Liu YY, Fan WH, Xu H, Liang XS. Viral infection parameters not nucleoside analogue itself correlates with host immunity in nucleoside analogue therapy for chronic hepatitis B. World J Gastroenterol. 2014 Jul 28;20(28):9486-96. doi: 10.3748/wjg.v20.i28.9486.
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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.
Wan Mo Bin, Professor study director
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telbivudine in people with HBeAg Positive Chronic Hepatitis B Infection, run by Cz Li 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 3 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 29 Nov 2011. 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?
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?
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy (time frame: base line-4 weeks-12 weeks-24 weeks-end of therapy). 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 NCT01480492, which also lists 1 linked publication.
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 29 Nov 2011.