Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
This study has been terminated.
(The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA))
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00376259
First received: September 13, 2006
Last updated: June 28, 2011
Last verified: June 2011
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Purpose
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: telbivudine Drug: adefovir dipivoxil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- The Proportion of Participants Who Experienced Virologic Breakthrough [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration [ Time Frame: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 43 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: telbivudine
600mg/day oral tablet for 96 weeks
Drug: adefovir dipivoxil
10 mg of adefovir by mouth once daily
Other Name: adefovir dipivoxil
|
|
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
Other Name: adefovir dipivoxil
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
- Previous or current lamivudine treatment
- HBV DNA > 6 log10 copies/mL
- Evidence of viral breakthrough
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding.
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376259
Locations
| United States, California | |
| Novartis | |
| San Diego, California, United States | |
| San Mateo, California, United States | |
| Hong Kong | |
| Pok Fu Lam, Hong Kong | |
| Korea, Republic of | |
| Seoul, Korea, Republic of | |
| Taiwan | |
| Novarits | |
| Kaohsuing, Taiwan | |
| Thailand | |
| Bangkok, Thailand | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00376259 History of Changes |
| Other Study ID Numbers: | CLDT600A2304 |
| Study First Received: | September 13, 2006 |
| Results First Received: | December 20, 2010 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
lamivudine resistance Hepatitis B virus |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Adefovir |
Adefovir dipivoxil Lamivudine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013