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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260610

Enrollment

Registered

2010-12-15

Start date

2011-06-30

Completion date

2011-06-30

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Tenofovir, Telbivudine

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.

Interventions

DRUGTenofovir

300 mg of Tenofovir daily

DRUGTelbivudine

600 mg of Telbivudine daily

DRUGTenofovir plus Telbivudine

Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Percentage of patients with virological breakthrough	24 weeks
Percentage change in serum HBV DNA levels	Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%	Baseline and 2 Years
Percentage of patients with primary treatment failure	12 weeks
Occurrence of adverse events	2 Years
Percentage of patients with ALT normalization	Baseline and 2 Years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026