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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00877149
First received: April 6, 2009
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Compensated Chronic Hepatitis B
Drug: telbivudine/LDT600
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion [ Time Frame: weeks 24, 52 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2009
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: telbivudine/LDT600

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877149

Locations
China
Beijing Ditan Hospital
Beijing, China
Peking University People's Hospital
Peking, China
First Hospital of Peking University
Peking, China
Ruijin Hospital, Affiliated to 2nd Medical university
Shanghai, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00877149     History of Changes
Other Study ID Numbers: CLDT600ACN04E1
Study First Received: April 6, 2009
Last Updated: May 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Chronic HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014