MedDataX Logo

Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis

NCT ID: NCT00663182

Last Updated: 2008-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B Virus Decompensated Cirrhosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Entecavir cirrhosis anti-viral therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Patients with decompensated HBV-related cirrhosis

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Entecavir 0.5 mg/d

B

Untreated

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Entecavir

Entecavir 0.5 mg/d

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Baraclude

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. over 16 years of age;
2. evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
3. Liver cirrhosis was proven by ultrasound or CT;
4. Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
5. patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy

Exclusion Criteria

1. evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
2. a serum alanine aminotransferase level more than 10 times the upper limit of normal
3. coinfection with hepatitis C or D virus or human immunodeficiency virus
4. other types of cirrhosis
5. a history of anti-viral therapy
6. a total bilirubin level higher than 170 mmol/L
7. a history of malignant tumors
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shanghai Changzheng Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jian Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 15470215 (View on PubMed)

Tseng 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.

Reference Type RESULT
PMID: 15985009 (View on PubMed)

Villeneuve 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.

Reference Type RESULT
PMID: 10613747 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Entecavir-01

Identifier Type: -

Identifier Source: org_study_id