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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:
ClinicalTrials.gov Identifier:
NCT00877149
First Posted: April 7, 2009
Last Update Posted: May 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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 ( Novartis Pharmaceuticals ):

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) ]

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 ]
  • 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 ]
  • To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion [ Time Frame: weeks 24, 52 and 24 weeks post-treatment ]
  • 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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877149


Locations
China
Beijing Ditan Hospital
Beijing, China
First Hospital of Peking University
Peking, China
Peking University People's Hospital
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00877149     History of Changes
Other Study ID Numbers: CLDT600ACN04E1
First Submitted: April 6, 2009
First Posted: April 7, 2009
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action