Study Stopped
lack of funds
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA \> 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
Trial Health
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Started Jun 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 16, 2015
June 1, 2011
Same day
December 14, 2010
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
6 Months and 2 Years
Secondary Outcomes (6)
Percentage change in serum HBV DNA levels
Baseline and 2 Years
Percentage of patients with ALT normalization
Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%
Baseline and 2 Years
Percentage of patients with virological breakthrough
24 weeks
Percentage of patients with primary treatment failure
12 weeks
- +1 more secondary outcomes
Study Arms (3)
Tenofovir
ACTIVE COMPARATORTelbivudine
ACTIVE COMPARATORTenofovir plus Telbivudine
EXPERIMENTALInterventions
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
Eligibility Criteria
You may qualify if:
- HBeAg negative at screening
- Documented chronic Hepatitis B
- Treatment naive
- Compensated liver disease
You may not qualify if:
- Chronic Hepatitis B with Child Pugh B \& C
- HBeAg positive
- Decompensated liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr S. K. Sarin, MD, DM
Institute of Liver & Biliary Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 15, 2010
Study Start
June 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 16, 2015
Record last verified: 2011-06