Phase 3
Completed N=1,869
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Source: ClinicalTrials.gov NCT00142298 ↗Enrolled (actual)
1,869
Serious AEs
6.7%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] — 67.2; 73.8; 81.7; 86.3 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015] |
67.2; 73.8; 81.7; 86.3 | — |
| PRIMARY Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015] |
60.1; 65.3; 80.8; 81.0 | — |
| PRIMARY Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010] |
77.7; 35.4; 69.8; 81.8; 46.7; 76.7 | — |
| PRIMARY Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301] |
100; 100; 72.7; 71.4; 80.0; 75.0 | — |
| PRIMARY Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301] |
100; 100; 72.7; 100; 80.0; 100 | — |
| PRIMARY Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)] |
69.8; 73.8; 57.1; 62.5; 0.0; 80.0 | — |
| PRIMARY Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies] |
— | — |
| SECONDARY To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment |
— | — |
| SECONDARY To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine |
— | — |
| SECONDARY To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients |
— | — |
| SECONDARY 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 |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00142298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.