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Trial record 79 of 131 for:    "Hepatitis" | "Lamivudine"

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

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ClinicalTrials.gov Identifier: NCT00376259
Recruitment Status : Terminated (The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA))
First Posted : September 14, 2006
Results First Posted : May 17, 2011
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B
Interventions Drug: telbivudine
Drug: adefovir dipivoxil
Enrollment 43
Recruitment Details Planned enrollment was 150 patients. At the time of study termination, 43 patients had been enrolled and randomized to study treatment and 42 patients received study drug (21 patients in the combination group and 21 in the monotherapy group).
Pre-assignment Details One patient was randomized but never received study drug treatment because he was discontinued on the randomization day due to sponsor request.
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Period Title: Overall Study
Started 22 21
Received Study Drug 21 21
Completed 0 0
Not Completed 22 21
Reason Not Completed
Sponsor request - study termination             21             21
Patient request             1             0
Arm/Group Title Combination Therapy Adefovir Monotherapy Total
Hide Arm/Group Description Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
36.8  (11.82) 39.0  (10.93) 37.9  (11.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
3
  13.6%
5
  23.8%
8
  18.6%
Male
19
  86.4%
16
  76.2%
35
  81.4%
1.Primary Outcome
Title The Proportion of Participants Who Experienced Virologic Breakthrough
Hide Description Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
Time Frame 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description:
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration
Hide Description Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.
Time Frame Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description:
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: Log10 Copies/mL
At Baseline (N = 21, 20) 10.240  (1.5750) 10.127  (0.9697)
At Week 12 4.405  (0.9944) 5.515  (1.3188)
Change from Baseline to Week 12 -5.835  (1.6435) -4.612  (1.7725)
At Baseline (N = 20, 20) 10.279  (1.6058) 10.127  (0.9697)
At Week 24 3.678  (1.0483) 5.161  (1.7364)
Change from Baseline to Week 24 -6.601  (1.7873) -4.966  (2.2851)
At Baseline (N = 13, 9) 10.652  (1.5203) 10.207  (0.7520)
At Week 48 3.274  (1.0254) 5.272  (1.9581)
Change from Baseline to Week 48 -7.378  (1.9303) -4.934  (2.1153)
At Baseline (N = 2, 3) 9.605  (0.7990) 10.097  (0.1484)
At Week 60 3.360  (0.3111) 4.330  (0.6110)
Change from Baseline to Week 60 -6.245  (0.4879) -5.767  (0.4650)
3.Secondary Outcome
Title Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria
Hide Description Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.
Time Frame 12 week, 24 week, 48 week and 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description:
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
Undetectable HBV DNA at week 12 4.8 5.0
Undetectable HBV DNA at week 24 15.0 10.0
Undetectable HBV DNA at week 48 38.5 0.0
Undetectable HBV DNA at week 60 0.0 0.0
Serum ALT normalization at week 12 40.0 25.0
Serum ALT normalization at week 24 55.0 35.0
Serum ALT normalization at week 48 69.2 33.3
Serum ALT normalization at week 60 50.0 0.0
HBeAg loss at week 12 0.0 0.0
HBeAg loss at week 24 5.0 5.0
HBeAg loss at week 48 23.1 0.0
HBeAg loss at week 60 0.0 0.0
HBeAg seroconversion at week 12 0.0 0.0
HBeAg seroconversion at week 24 0.0 0.0
HBeAg seroconversion at week 48 15.4 0.0
HBeAg seroconversion at week 60 0.0 0.0
HBsAg loss at week 12 0.0 0.0
HBsAg loss at week 24 0.0 0.0
HBsAg loss at week 48 0.0 0.0
HBsAg loss at week 60 0.0 0.0
HBsAg seroconversion at week 12 0.0 0.0
HBsAg seroconversion at week 24 0.0 0.0
HBsAg seroconversion at week 48 0.0 0.0
HBsAg seroconversion at week 60 0.0 0.0
4.Secondary Outcome
Title Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough
Hide Description The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description:
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population.
 
Arm/Group Title Combination Therapy Adefovir Monotherapy
Hide Arm/Group Description Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
All-Cause Mortality
Combination Therapy Adefovir Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Therapy Adefovir Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   0/21 (0.00%) 
Injury, poisoning and procedural complications     
Hand fracture  1  1/21 (4.76%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Therapy Adefovir Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   14/21 (66.67%)   11/21 (52.38%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/21 (0.00%)  2/21 (9.52%) 
Dyspepsia  1  0/21 (0.00%)  2/21 (9.52%) 
General disorders     
Fatigue  1  1/21 (4.76%)  3/21 (14.29%) 
Hepatobiliary disorders     
Hepatic steatosis  1  2/21 (9.52%)  2/21 (9.52%) 
Infections and infestations     
Nasopharyngitis  1  3/21 (14.29%)  0/21 (0.00%) 
Rhinitis  1  1/21 (4.76%)  2/21 (9.52%) 
Upper respiratory tract infection  1  5/21 (23.81%)  8/21 (38.10%) 
Investigations     
Blood creatine phosphokinase increased  1  3/21 (14.29%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/21 (9.52%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00376259     History of Changes
Other Study ID Numbers: CLDT600A2304
First Submitted: September 13, 2006
First Posted: September 14, 2006
Results First Submitted: December 20, 2010
Results First Posted: May 17, 2011
Last Update Posted: June 30, 2011