Liver FailurePhase 2NCT01254994
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
A Phase 2 study testing entecavir and Traditional comprehensive medical treatment in people with Liver Failure, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure
- What is being tested?
- entecavir and Traditional comprehensive medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Dec 2010
- Phase
- Phase 2
- 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
Who may be able to join
- ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.
- age >18 years
- HBV DNA > 3log10 copy/mL
Who cannot join
- Pregnant or lactating women.
- Diagnosed or suspected as hepatic carcinoma patients.
- Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
- Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
- A history of drug abuse or alcohol abuse.
- Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.
- A history of using immunomodulator including steroids
- Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.
- Conditions
- Liver Failure
- Being tested
- entecavir, Traditional comprehensive medical treatment
- Keywords
- hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting
- Medical subject headings
- Liver Failure, Hepatitis B, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entecavirDrug
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
Traditional comprehensive medical treatmentDrug
bed rest, sufficient energy and vitamins, reduced glutathione, prostaglandin E1, hepatocyte growth factor (HGF), plasma and albumin, maintenance of water and electrolyte balance, and prevention and treatment of complications, such as infections, hepatic encephalopathy, hemorrhage, hepatorenal syndrome and ascites.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients were prescribed the tradition comprehensive medical treatment without entecavir. Receives: Drug: Traditional comprehensive medical treatment |
| ETV group | Experimental | All the patients were prescribed the tradition comprehensive medical treatment with entecavir. Entecavir was supplied by the Sino-US Shanghai Squibb Pharmaceutical Co., Ltd. Patients took 0.5 mg entecavir following oral fasting one time per day. Receives: Drug: entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA level and liver function
HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)
Measured: 48 weeks
Secondary outcomes (1)
Symptoms,signs and mortality
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Lin B Liang, MD, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254994
- Sponsor's protocol ID
- Entecavir
- Status last verified
- Aug 2007
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
- ClinicalTrials.gov ID
- NCT01254994
- Acronym / sponsor ID
- Entecavir
- Conditions
- Liver Failure
- Keywords
- hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Dec 2010 (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.
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Traditional comprehensive medical treatmentThe patients were prescribed the tradition comprehensive medical treatment without entecavir. |
| ETV group | Experimental | Drug: entecavirAll the patients were prescribed the tradition comprehensive medical treatment with entecavir. Entecavir was supplied by the Sino-US Shanghai Squibb Pharmaceutical Co., Ltd. Patients took 0.5 mg entecavir following oral fasting one time per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.
- age >18 years
- HBV DNA > 3log10 copy/mL
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Diagnosed or suspected as hepatic carcinoma patients.
- Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
- Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
- A history of drug abuse or alcohol abuse.
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 |
|---|---|---|
| entecavirPatients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day. | Drug | ETV group |
| Traditional comprehensive medical treatmentbed rest, sufficient energy and vitamins, reduced glutathione, prostaglandin E1, hepatocyte growth factor (HGF), plasma and albumin, maintenance of water and electrolyte balance, and prevention and treatment of complications, such as infections, hepatic encephalopathy, hemorrhage, hepatorenal syndrome and ascites. | Drug | Control group |
Primary outcome
HBV DNA level and liver function
Time frame: 48 weeks
HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)
1 secondary outcome
Symptoms,signs and mortality
Time frame: 48 weeks
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 7 Dec 2010.
- The Third Affiliated Hospital of Sun Yat-sen UniversityLink provided by the sponsor.
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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.
Lin B Liang, MD principal investigator
Third Affiliated Hospital, 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 Phase 2 study testing entecavir and Traditional comprehensive medical treatment in people with Liver Failure, run by 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 3 inclusion and 8 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 7 Dec 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HBV DNA level and liver function (time frame: 48 weeks). 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 7 Dec 2010.