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Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

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Novartis

Status and phase

Completed
Phase 2

Conditions

Hepatitis B

Treatments

Drug: valtorcitabine
Drug: telbivudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00128544
NV-02C-004

Details and patient eligibility

About

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical history compatible with compensated chronic hepatitis B

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
  • Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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