Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00142298
First received: August 31, 2005
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Telbivudine (LdT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] [ Time Frame: 156 weeks, 208 weeks (from feeder study baseline) ] [ Designated as safety issue: No ]
    The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  • Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] [ Time Frame: 52 weeks, 104 weeks ] [ Designated as safety issue: No ]
    The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  • Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] [ Time Frame: 52 weeks, 104 weeks ] [ Designated as safety issue: No ]
    The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  • Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301] [ Time Frame: 156 weeks, 208 weeks (from feeder study baseline) ] [ Designated as safety issue: No ]
    Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.

  • Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301] [ Time Frame: 52 weeks,104 weeks ] [ Designated as safety issue: No ]
    Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.

  • Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)] [ Time Frame: 52 weeks,104 weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  • Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies] [ Time Frame: 52 weeks,104 weeks ] [ Designated as safety issue: No ]

    The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.

    Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.



Secondary Outcome Measures:
  • To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment [ Time Frame: 52 weeks, 104 weeks, 156 weeks, 208 weeks ] [ Designated as safety issue: No ]
  • To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine [ Time Frame: 52 weeks, 104 weeks, 156 weeks, 208 weeks ] [ Designated as safety issue: No ]
  • To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients [ Time Frame: 52 weeks, 104 weeks, 156 weeks, 208 weeks ] [ Designated as safety issue: No ]
  • To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough [ Time Frame: 52 weeks, 104 weeks, 156 weeks, 208 weeks ] [ Designated as safety issue: No ]

Enrollment: 1869
Study Start Date: March 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Telbivudine (LdT)
    Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
    Other Names:
    • Sebivo®/Tyzeka®
    • LdT600
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
  • Patient was not discontinued from previous Idenix-Sponsored study

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C, hepatitis D or HIV

Other protocol-defined 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: NCT00142298

  Show 39 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: novartis
ClinicalTrials.gov Identifier: NCT00142298     History of Changes
Other Study ID Numbers: CLDT600A2303
Study First Received: August 31, 2005
Results First Received: January 12, 2011
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014