Severe Acute Exacerbation of Chronic Hepatitis BNCT01627236
Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
A study testing methylprednisolone in people with Severe Acute Exacerbation of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Acute Exacerbation of Chronic Hepatitis B
- What is being tested?
- methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Nov 2014
- 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
- serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
- All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
- serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%;
- serum ALT of 20 times or more the ULN.
Who cannot join
- superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
- other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
- ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
- decompensated liver cirrhosis;
- severe bacterial or fungal infections;
- a history of diabetes or cardiac disease or hypertension or nephrosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 020
Zhe-bin Wu, resident physician, 13751743264, wzbice1982@sohu.com
Zhe-bin Wu, resident physician
About this study
The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.
- Being tested
- methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoid treatment group | Experimental | Not described Receives: Drug: methylprednisolone |
| conventional treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: eight weeks
liver function
ALT,albumin,bilirubine,
Measured: eight weeks
HBV-DNA
Measured: eight weeks
prothrombin activity
Measured: eight weeks
Child-Pugh degree
Measured: eight weeks
model for end-stage liver disease
Measured: eight weeks
Secondary outcomes (2)
length of patient stay
Measured: eight weeks
hospitalization costs
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Exacerbation of 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhi-liang Gao, professor, Study director, Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627236
- Sponsor's protocol ID
- zssywzb01
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2012
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01627236
- Acronym / sponsor ID
- zssywzb01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 25 Jun 2012 (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.
The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucocorticoid treatment group | Experimental | Drug: methylprednisolone |
| conventional treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
- All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
- serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%;
- serum ALT of 20 times or more the ULN.
Key exclusion criteria (6 listed)
- superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
- other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
- ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
- decompensated liver cirrhosis;
- severe bacterial or fungal infections;
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 |
|---|---|---|
| methylprednisolonemethylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid | Drug | glucocorticoid treatment group |
Primary outcome
survival rate
Time frame: eight weeks
liver function
Time frame: eight weeks
ALT,albumin,bilirubine,
HBV-DNA
Time frame: eight weeks
prothrombin activity
Time frame: eight weeks
Child-Pugh degree
Time frame: eight weeks
model for end-stage liver disease
Time frame: eight weeks
2 secondary outcomes
length of patient stay
Time frame: eight weeks
hospitalization costs
Time frame: eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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.
Zhi-liang Gao, professor study director
Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone in people with Severe Acute Exacerbation of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University 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 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 10 Oct 2013. 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 Zhe-bin Wu, resident physician (13751743264, wzbice1982@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: eight weeks). The study lists 6 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 10 Oct 2013.