Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142298
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2005-08-31
Brief Title:
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open Label Trial of Telbivudine LdT in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inclusionexclusion criteria The feeder studies were as follows
CLDT600A2302 NV-02B-007NCT00057265 the GLOBE study was a Phase III randomized doubleblindmulti-center 104-week pivotal study of telbivudine vs lamivudine in treatment of naïve patients with compensated chronic hepatitis B CLDT600A2302NV-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 mgday to lamivudine 100 mgday 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-011NCT00076336 was a Phase III randomized double-blind multi-center 104-week pivotal study of telbivudine 600 mgday vs lamivudine 100 mgday in treatment-naïve adults with decompensated chronic hepatitis B CLDT600A2301NV-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-center52-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 CLDT600A2401NV-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 CLDT600A2402NV-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 2302015 and enrolled into group A and for all patients in group A from studies 24012402010 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 2302015 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
CLDT600A2302 NV-02B-007NCT00057265 the GLOBE study was a Phase III randomized doubleblindmulti-center 104-week pivotal study of telbivudine vs lamivudine in treatment of naïve patients with compensated chronic hepatitis B CLDT600A2302NV-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 mgday to lamivudine 100 mgday 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-011NCT00076336 was a Phase III randomized double-blind multi-center 104-week pivotal study of telbivudine 600 mgday vs lamivudine 100 mgday in treatment-naïve adults with decompensated chronic hepatitis B CLDT600A2301NV-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-center52-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 CLDT600A2401NV-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 CLDT600A2402NV-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 2302015 and enrolled into group A and for all patients in group A from studies 24012402010 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 2302015 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NV-02B-022 | OTHER | Idenix | None |