deltatrials
Unknown PHASE4 INTERVENTIONAL 2-arm NCT00663182

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

Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

Sponsor: Shanghai Changzheng Hospital

Interventions Entecavir
Updated 6 times since 2017 Last updated: Apr 22, 2008 Started: Jan 31, 2008 Primary completion: Dec 31, 2010 Completion: Dec 31, 2012

Listed as NCT00663182, this PHASE4 trial focuses on Decompensated Cirrhosis and Hepatitis B Virus and remains ongoing. Sponsored by Shanghai Changzheng Hospital, it has been updated 6 times since 2008, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotEnrolling By Invitation~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE4

    Status: Unknown StatusUnknown

  3. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE4

  5. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE4

    Status: Enrolling By InvitationUnknown Status

Show 1 earlier version
  1. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation PHASE4

    First recorded

Jan 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai Changzheng Hospital
Data source: Shanghai Changzheng Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations