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Completed

NCT Number: NCT00877149

Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients

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Key information

Conditions

Compensated Chronic Hepatitis B

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Ditan Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
  • Patient was not discontinued from the previous CLDT600ACN04 study.
  • Adult patients with CHB (HBeAg positive or HBeAg negative).
  • HBV DNA PCR undetectable in recent 12 months.

Exclusion criteria

  • Pregnant or breastfeeding, or has plan of pregnant during study period.
  • Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
  • Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

telbivudine/LDT600

Drug

Primary outcomes

  1. To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.

    Time frame: Visit 2 (week 1)

Secondary outcomes

  1. To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment

    Time frame: weeks 1, 24, 52 and 24 weeks post-treatment

  2. To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies

    Time frame: weeks 24 and 52, 24 weeks post-treatment

  3. To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion

    Time frame: weeks 24, 52 and 24 weeks post-treatment

  4. To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015

    Time frame: Visit 2 (week 1)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B

Important dates

Study start
2009
Primary completion
2011
First posted
Apr 7, 2009
Registry last updated
May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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