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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Drug: telbivudine Drug: adefovir dipivoxil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||August 2008|
Experimental: Combination therapy
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
600mg/day oral tablet for 96 weeksDrug: adefovir dipivoxil
10 mg of adefovir by mouth once daily
Active Comparator: Adefovir monotherapy
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Drug: adefovir dipivoxil
10 mg of adefovir by mouth once daily
- The Proportion of Participants Who Experienced Virologic Breakthrough [ Time Frame: 96 Weeks ]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.
- Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration [ Time Frame: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks ]Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.
- Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria [ Time Frame: 12 week, 24 week, 48 week and 60 weeks ]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.
- Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough [ Time Frame: Week 96 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376259
|United States, California|
|San Diego, California, United States|
|San Mateo, California, United States|
|Pok Fu Lam, Hong Kong|
|Korea, Republic of|
|Seoul, Korea, Republic of|