Chronic Hepatitis BNCT01471535
HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated
A study testing Pegylated interferon alfa-2a in people with Chronic Hepatitis B, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Pegylated interferon alfa-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBsAg positive and anti-HBs negative for more than 6 months
- HBeAg-negative/anti-HBe-positive
- Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
- Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
- Absence of previous antiviral therapy
Who cannot join
- With active alcohol and/or drugs consumption
- With human immunodeficiency virus or hepatitis C virus coinfections
- With clinical evidence of cirrhosis
- With history of autoimmune hepatitis
- With hematological or psychiatric diseases
- With evidence of neoplastic diseases
- With severe cardiac or pulmonary disease
Trial locations and contacts
1 site in 1 country.
China1 site
liver disease center, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
About this study
Official title: HBsAg Loss/Seroconversion in Inactive Chronic Hepatitis B Carriers Treated With Peginterferon Alpha-2a
Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers.
The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.
Read the detailed description
Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two occasions during the month prior to treatment. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with weekly subcutaneous injections of peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, the only parameter to assessing the treatment response was HBsAg level change. Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as seroconversion.
Depending on the decline of HBsAg level, treatment was either continued for a prolonged period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels on three months treatment.
Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral blood neutrophil and platelet count were detected before treatment, and monitored during treatment with one to three month intervals, and base on the test results to adjust the next checking time. Quantitative HBV DNA testing was conducted using a commercially available real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect i2000 HBsAg quantitative assay (Abbott Laboratories) kit.
The main efficacy endpoints were HBsAg loss and seroconversion.
- Conditions
- Chronic Hepatitis B
- Being tested
- Pegylated interferon alfa-2a
- Keywords
- chronic hepatitis B
- 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.
Pegylated interferon alfa-2aDrug
Also called Pegasys®; Roche, Basel, Switzerland
patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks
| Study group | Role | What they receive |
|---|---|---|
| peginterferon alpha 2a | Experimental | the inactive chronic HBsAg carriers were treated with peginterferon alpha 2a for 72 weeks and followed for 24 weeks. Receives: Drug: Pegylated interferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg loss/seroconversion
HBsAg loss was defined as HBsAg levels <0.05 IU/mL. Anti-HBs was measured using Architect i2000 kit,and anti-HBs >10 mIU/L was considered positive.
Measured: HBsAg level was lower than 0.05IU/mL after 96 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionDec 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Yao Xie, phD/MD, Principal investigator, Liver diseases center, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471535
- Sponsor's protocol ID
- DTH-XY002
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBsAg Loss/Seroconversion in Inactive Chronic Hepatitis B Carriers Treated With Peginterferon Alpha-2a
- ClinicalTrials.gov ID
- NCT01471535
- Acronym / sponsor ID
- DTH-XY002
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 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.
Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers.
The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.
Detailed description
Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two occasions during the month prior to treatment. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with weekly subcutaneous injections of peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, the only parameter to assessing the treatment response was HBsAg level change. Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as seroconversion.
Depending on the decline of HBsAg level, treatment was either continued for a prolonged period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels on three months treatment.
Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral blood neutrophil and platelet count were detected before treatment, and monitored during treatment with one to three month intervals, and base on the test results to adjust the next checking time. Quantitative HBV DNA testing was conducted using a commercially available real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect i2000 HBsAg quantitative assay (Abbott Laboratories) kit.
The main efficacy endpoints were HBsAg loss and seroconversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peginterferon alpha 2a | Experimental | Drug: Pegylated interferon alfa-2athe inactive chronic HBsAg carriers were treated with peginterferon alpha 2a for 72 weeks and followed for 24 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HBsAg positive and anti-HBs negative for more than 6 months
- HBeAg-negative/anti-HBe-positive
- Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
- Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
- Absence of previous antiviral therapy
Key exclusion criteria (7 listed)
- With active alcohol and/or drugs consumption
- With human immunodeficiency virus or hepatitis C virus coinfections
- With clinical evidence of cirrhosis
- With history of autoimmune hepatitis
- With hematological or psychiatric diseases
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 |
|---|---|---|
| Pegylated interferon alfa-2aAlso: Pegasys®; Roche, Basel, Switzerlandpatients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks | Drug | peginterferon alpha 2a |
Primary outcome
HBsAg loss/seroconversion
Time frame: HBsAg level was lower than 0.05IU/mL after 96 weeks treatment
HBsAg loss was defined as HBsAg levels <0.05 IU/mL. Anti-HBs was measured using Architect i2000 kit,and anti-HBs >10 mIU/L was considered positive.
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 10 Mar 2015.
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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.
Yao Xie, phD/MD principal investigator
Liver diseases center, Beijing Ditan 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 Pegylated interferon alfa-2a in people with Chronic Hepatitis B, run by Beijing Ditan 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 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 10 Mar 2015. 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?
HBsAg loss/seroconversion (time frame: HBsAg level was lower than 0.05IU/mL after 96 weeks treatment). 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 10 Mar 2015.