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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Chronic Hepatitis B

Treatments: Drug: Telbivudine; Drug: Tenofovir plus Telbivudine; Drug: Tenofovir

Study type: Interventional

Funder types: Other

Identifiers

NCT01260610

CLDT600AIN05T

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Tenofovir

Active Comparator group

Treatment:

Drug: Tenofovir

Telbivudine

Active Comparator group

Treatment:

Drug: Telbivudine

Tenofovir plus Telbivudine

Experimental group

Treatment:

Drug: Tenofovir plus Telbivudine