Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      Patients from 6 feeder trials could be eligible to enter current study CLDT600A2303 (
      NCT00142298) if they met inclusion/exclusion criteria. The feeder studies were as follows:

        -  CLDT600A2302 (NV-02B-007)(NCT00057265), the GLOBE study, was a Phase III, randomized,
           doubleblind,multi-center, 104-week, pivotal study of telbivudine vs. lamivudine in
           treatment of naïve patients with compensated chronic hepatitis B.
           CLDT600A2302/NV-02B-007 (NCT00057265) is hereafter referred to as study 2302.

        -  NV-02B-015 (NCT00131742) was a Phase III, randomized, double-blind, 104-week study
           comparing the efficacy and safety of telbivudine (600 mg/day) to lamivudine (100 mg/day)
           in treatment of naïve Chinese patients with compensated chronic hepatitis B. NV-02B-015
           (NCT00131742) is hereafter referred to as study 015.

        -  CLDT600A2301 (NV-02B-011)(NCT00076336) was a Phase III, randomized double-blind,
           multi-center, 104-week, pivotal study of telbivudine (600 mg/day) vs. lamivudine (100
           mg/day) in treatment-naïve adults with decompensated chronic hepatitis B.
           CLDT600A2301/NV-02B-011 (NCT00076336) is hereafter referred to as study 2301.

        -  NV-02B-010 (NCT00124241) was a Phase IIb, 104-week extension study of telbivudine,
           lamivudine or the combination of both agents in patients with chronic hepatitis B who
           had completed the core study NV-02B-003 (NCT00124241). NV-02B-010 (NCT00124241) is
           hereafter referred to as study 010.

      NV-02B-003 (NCT00124241) was a Phase IIa, 52-week study of telbivudine, lamivudine or the
      combination of both agents in patients with HBeAg-positive chronic hepatitis B.

        -  CLDT600A2401 (NV-02B-018) (NCT00115245) was a Phase IIIb, randomized, open-label,
           multi-center,52-week study of telbivudine vs. adefovir dipivoxil for 24 weeks then a
           switch to telbivudine for another 28 weeks in treatment-naïve patients with compensated
           chronic hepatitis B. CLDT600A2401/NV-02B-018 (NCT00115245) is hereafter referred to as
           study 2401.

        -  CLDT600A2402 (NV-02B-019) (NCT00132652) was a Phase IIIb, randomized, open-label,
           multi-center, 52-week study of switching lamivudine to telbivudine vs. continued on
           lamivudine treatment in adults with compensated chronic hepatitis B who were previously
           treated with lamivudine for 3-12 months. CLDT600A2402/NV-02-019 (NCT00132652) is
           hereafter referred to as study 2402.

      PATIENT GROUPS:

      GROUP A: Patients with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B who did not
      discontinue treatment in their previous study due to an efficacy response and required
      further treatment or who had met the criteria for discontinuation of treatment in their
      previous study due to efficacy, but were being maintained on study drug by the principal
      investigator. For patients treated with telbivudine who enrolled into Group A from studies
      2302 and 015, the total telbivudine treatment time (starting from feeder study baseline to
      the end of the on-treatment period in study 2303) was 208 weeks. For patients treated with
      lamivudine in studies 2302/015 and enrolled into group A and for all patients in group A from
      studies 2401/2402/010, the total telbivudine treatment time was 104 weeks.

      GROUP B: Patients with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B who did not
      discontinue treatment in their previous study due to an efficacy response and required
      further treatment. Patients treated with telbivudine in study 2301 were enrolled to group B
      and the total telbivudine treatment time (starting from feeder study baseline to the end of
      the on-treatment period in study 2303) was 208 weeks. For patients treated with lamivudine in
      study 2301 and enrolled into group B, the total telbivudine treatment time was 104 weeks.

      GROUP C: Patients with either compensated or decompensated chronic hepatitis B, who had
      discontinued study drug treatment in their previous Idenix-sponsored study due to an efficacy
      response as recommended by protocol. Patients who were eligible for treatment discontinuation
      in their previous study but who were, at the principal investigators discretion, continued on
      study therapy, were eligible to enter this study in Group C provided their treatment was
      discontinued at their last visit of the previous study. The feeder studies for group C of
      current study were study 2302/015, 2401, 2402, and 010. For patients who enrolled into group
      C, total telbivudine treatment time was 104 weeks starting from the baseline of the feeder
      studies to their last visit of the feeder studies. Patients were enrolled to current study
      (study 2303) for off-treatment follow-up after the treatment discontinuation due to efficacy.
      Hence, patients did not receive any study drug except in case of patients who relapsed and
      reinitiated treatment.
    

Intervention name(s): Telbivudine (LdT)
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Sebivo®/Tyzeka®; LdT600
Intervention MeSH terms: Telbivudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment