Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Tenofovir (Drug); Telbivudine (Drug); Tenofovir plus Telbivudine (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Institute of Liver and Biliary Sciences, India Official(s) and/or principal investigator(s): Dr S. K. Sarin, MD, DM, Principal Investigator, Affiliation: Institute of Liver & Biliary Sciences
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.
Clinical Details
Official title: An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Secondary outcome: Percentage change in serum HBV DNA levelsPercentage of patients with ALT normalization Percentage of patients with reduction in HBsAg concentration by >50% Percentage of patients with virological breakthrough Percentage of patients with primary treatment failure Occurrence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HBeAg negative at screening
- Documented chronic Hepatitis B
- Treatment naive
- Compensated liver disease
Exclusion Criteria:
- Chronic Hepatitis B with Child Pugh B & C
- HBeAg positive
- Decompensated liver disease
Locations and Contacts
Institute of Liver & Biliary Sciences, New Delhi, India
Additional Information
Starting date: June 2011
Last updated: June 15, 2015
|