Hepatitis B VirusPhase 4NCT00663182
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
A Phase 4 study testing Entecavir in people with Hepatitis B Virus and Decompensated Cirrhosis, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B Virus, Decompensated Cirrhosis
- What is being tested?
- Entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2012
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- over 16 years of age;
- evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
- Liver cirrhosis was proven by ultrasound or CT;
- Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
- patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy
Who cannot join
- evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
- a serum alanine aminotransferase level more than 10 times the upper limit of normal
- coinfection with hepatitis C or D virus or human immunodeficiency virus
- other types of cirrhosis
- a history of anti-viral therapy
- a total bilirubin level higher than 170 mmol/L
- a history of malignant tumors
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
Official title: Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
Read the detailed description
Chronic hepatitis B is one of the most widespread viral infections worldwide, potentially leading to liver cirrhosis and hepatocellular carcinoma. Previous studies demonstrated that patients with active viral replication, defined as the presence of detectable serum HBV-DNA or HBeAg, were at increased risk of developing progressive liver disease or death.The prognosis of decompensated cirrhosis resulting from chronic hepatitis B virus infection is poor. Anti-viral therapy in decompensated HBV-related cirrhosis has been recommended by the American Association for the Study of Liver Diseases. However, no high quality research on the effectiveness of anti-viral therapy in decompensated cirrhosis has been performed.
Entecavir is a new nucleotide analogue, which has been proved effective in suppressing viral replication and decreasing the necroinflammatory response, was recommended as a first-line medication in AASLD guideline. Our purpose was to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. The main outcomes were liver function, HBV-DNA, disease progression, hepatocellular carcinoma, Child-Pugh score and the survival.
- Conditions
- Hepatitis B Virus, Decompensated Cirrhosis
- Being tested
- Entecavir
- Keywords
- Entecavir, cirrhosis, anti-viral, therapy
- Medical subject headings
- Hepatitis B, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude
Entecavir 0.5 mg/d
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients with decompensated HBV-related cirrhosis Receives: Drug: Entecavir |
| B | No intervention | Untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver function
Measured: 1 year
HBV-DNA
Measured: 1 year
Secondary outcomes (4)
disease progression
Measured: 2 years
hepatocellular carcinoma
Measured: 2 year
Child-Pugh score
Measured: 2 year
motality
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jian Shi, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663182
- Sponsor's protocol ID
- Entecavir-01
- Status last verified
- Apr 2008
- First submitted
- 21 Apr 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.
PubMed 15470215Tseng PL, Lu SN, Tung HD, Wang JH, Changchien CS, Lee CM. Determinants of early mortality and benefits of lamivudine therapy in patients with hepatitis B virus-related decompensated liver cirrhosis. J Viral Hepat. 2005 Jul;12(4):386-92. doi: 10.1111/j.1365-2893.2005.00608.x.
PubMed 15985009Villeneuve JP, Condreay LD, Willems B, Pomier-Layrargues G, Fenyves D, Bilodeau M, Leduc R, Peltekian K, Wong F, Margulies M, Heathcote EJ. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. Hepatology. 2000 Jan;31(1):207-10. doi: 10.1002/hep.510310130.
PubMed 10613747
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00663182
- Acronym / sponsor ID
- Entecavir-01
- Conditions
- Hepatitis B Virus, Decompensated Cirrhosis
- Keywords
- Entecavir, cirrhosis, anti-viral, therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 22 Apr 2008 (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 aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
Detailed description
Chronic hepatitis B is one of the most widespread viral infections worldwide, potentially leading to liver cirrhosis and hepatocellular carcinoma. Previous studies demonstrated that patients with active viral replication, defined as the presence of detectable serum HBV-DNA or HBeAg, were at increased risk of developing progressive liver disease or death.The prognosis of decompensated cirrhosis resulting from chronic hepatitis B virus infection is poor. Anti-viral therapy in decompensated HBV-related cirrhosis has been recommended by the American Association for the Study of Liver Diseases. However, no high quality research on the effectiveness of anti-viral therapy in decompensated cirrhosis has been performed.
Entecavir is a new nucleotide analogue, which has been proved effective in suppressing viral replication and decreasing the necroinflammatory response, was recommended as a first-line medication in AASLD guideline. Our purpose was to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. The main outcomes were liver function, HBV-DNA, disease progression, hepatocellular carcinoma, Child-Pugh score and the survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EntecavirPatients with decompensated HBV-related cirrhosis |
| B | No intervention | –Untreated |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- over 16 years of age;
- evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
- Liver cirrhosis was proven by ultrasound or CT;
- Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
- patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy
Key exclusion criteria (7 listed)
- evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
- a serum alanine aminotransferase level more than 10 times the upper limit of normal
- coinfection with hepatitis C or D virus or human immunodeficiency virus
- other types of cirrhosis
- a history of anti-viral therapy
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 |
|---|---|---|
| EntecavirAlso: BaracludeEntecavir 0.5 mg/d | Drug | A |
Primary outcome
liver function
Time frame: 1 year
HBV-DNA
Time frame: 1 year
4 secondary outcomes
disease progression
Time frame: 2 years
hepatocellular carcinoma
Time frame: 2 year
Child-Pugh score
Time frame: 2 year
motality
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Results publication: PubMed 15470215Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.
- Results publication: PubMed 15985009Tseng PL, Lu SN, Tung HD, Wang JH, Changchien CS, Lee CM. Determinants of early mortality and benefits of lamivudine therapy in patients with hepatitis B virus-related decompensated liver cirrhosis. J Viral Hepat. 2005 Jul;12(4):386-92. doi: 10.1111/j.1365-2893.2005.00608.x.
- Results publication: PubMed 10613747Villeneuve JP, Condreay LD, Willems B, Pomier-Layrargues G, Fenyves D, Bilodeau M, Leduc R, Peltekian K, Wong F, Margulies M, Heathcote EJ. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. Hepatology. 2000 Jan;31(1):207-10. doi: 10.1002/hep.510310130.
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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.
Jian Shi, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir in people with Hepatitis B Virus and Decompensated Cirrhosis, run by Shanghai Changzheng 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: status not confirmed, as of the sponsor's last update on 23 Apr 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
liver function (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT00663182, which also lists 3 linked publications.
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 23 Apr 2008.