Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Not Applicable

Withdrawn

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Tenofovir plus Telbivudine; Drug: Tenofovir; Drug: Telbivudine

• Registration Number: NCT01260610
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Status Verified: 2011-06
• Study Start: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir plus Telbivudine	Tenofovir plus Telbivudine	-
Tenofovir	Tenofovir	-
Telbivudine	Telbivudine	-

Primary Outcome Measures

Name	Time	Method
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone	6 Months and 2 Years

Secondary Outcome Measures

Name	Time	Method
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
Percentage change in serum HBV DNA levels	Baseline and 2 Years
Percentage of patients with ALT normalization	Baseline and 2 Years
Occurrence of adverse events	2 Years

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, India